Phytosterols

Evidence-based effects and studies

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Effects
393
Total evidences
804

Effects and Evidences

Detailed analysis of research findings

LDL-C

14 evidences

A combined nutraceutical containing bergamot extract and phytosterols improved triglycerides, LDL-C, and insulin resistance markers versus placebo in overweight dyslipidemic subjects.

Trust comment: Well-controlled RCT but uses a multi-ingredient product, so phytosterol-specific effects cannot be isolated.

Study Details

PMID:31225673
Participants:90
Impact:decrease (significant)
Trust score:3/5

Randomized trial comparing rosuvastatin vs placebo and various dietary supplements found rosuvastatin markedly reduced LDL-C; none of the tested dietary supplements (not including elemental calcium) reduced LDL-C versus placebo.

Trust comment: Randomized clinical trial with 190 completers and prespecified endpoints; single-center and single-blind but appropriately powered and registered.

Study Details

PMID:36351465
Participants:190
Impact:No significant decrease with plant sterols vs placebo (supplements overall showed no significant LDL-C reduction)
Trust score:4/5

Patient-level pooled analysis of two dietary RCTs assessing adherence to the Portfolio Diet (which includes plant sterols) and change in HbA1c over 6 months; greater adherence was associated with modest reductions in HbA1c and improvements in lipid measures, while intake of plant sterols showed minimal change in this cohort.

Trust comment: Patient-level pooled analysis of two RCTs with 267 participants; secondary analysis with limited change in the plant‑sterols pillar, so indirect evidence for phytosterols.

Study Details

PMID:39275135
Participants:267
Impact:−0.03 mmol/L per c-PDS point (p=0.016)
Trust score:3/5

Three-week double-blind RCT: daily 1.5 g phytosterols in low-fat milk reduced LDL-C and total cholesterol and modestly lowered diastolic blood pressure versus placebo.

Trust comment: Large, double-blind randomized placebo-controlled trial (n=221) with clear lipid endpoint reductions though short duration (3 weeks).

Study Details

PMID:28117400
Participants:221
Impact:−0.265 mmol/L (LS mean vs placebo); −4.58% in treatment group
Trust score:4/5

Four-month double-blind RCT of a multi-ingredient supplement (includes 1.8 g phytosterols/day) found no significant change in LDL-C or other lipid and oxidative markers versus placebo.

Trust comment: Well-conducted double-blind RCT but small sample (n=42) and multi-ingredient formulation prevents isolating phytosterol-specific effects.

Study Details

PMID:40147213
Participants:42
Impact:No significant change (adjusted mean difference −0.12 mmol/L; p=0.307)
Trust score:3/5

Three-month double-blind RCT of a monacolin K–free nutraceutical (contains phytosterols 400 mg per capsule, two capsules/day) found no significant changes in LDL-C, total cholesterol, triglycerides or inflammatory markers versus placebo.

Trust comment: Randomized double-blind RCT with moderate sample size (125 randomized, 118 completed) but low phytosterol dose in the combination and multi-ingredient confounding limit attribution.

Study Details

PMID:35889769
Participants:118
Impact:No significant change at 6 or 12 weeks
Trust score:3/5

Eight-week double-blind RCT: soymilk with 2 g/day phytosterols (and 10 g/day inulin) twice daily produced significant LDL-C and total cholesterol reductions versus standard soymilk (effect apparent from week 2).

Trust comment: Large, well-blinded randomized controlled trial (240 randomized, 227 analyzed) showing clinically meaningful LDL-C and TC reductions over 8 weeks.

Study Details

PMID:26553006
Participants:227
Impact:Median −10.03% (study) vs −1.31% (control); absolute median from 165 to 150 mg/dL in study group (p<0.001)
Trust score:5/5

In HIV patients on HAART, phytosterol 2 g/day for 4 weeks modestly lowered LDL and total cholesterol; adding phytosterols to pravastatin did not further reduce LDL versus pravastatin alone.

Trust comment: Randomized cross-over with objective lipid measures but small sample and open-label design limit generalizability.

Study Details

PMID:26148680
Participants:33
Impact:-9.12%
Trust score:4/5

A multi-ingredient nutraceutical containing sterol esters/stanols improved fasting and post‑prandial lipid profile and reduced endothelial damage markers after 3 months versus placebo.

Trust comment: Randomized placebo-controlled trial with adequate size but uses a multi-component product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:29655700
Participants:80
Impact:decrease (p<0.05)
Trust score:3/5

In metabolic syndrome patients on a western diet, 4 g/day phytosterols for 2 months significantly reduced total cholesterol, LDL‑C, small dense LDL, apoB, and triglycerides.

Trust comment: Randomized, placebo-controlled trial with a substantial sample and clear lipid endpoints.

Study Details

PMID:21316934
Participants:108
Impact:-20.3%
Trust score:5/5

3-week randomized double-blind trial: sterol-enriched milk lowered LDL cholesterol and showed strong HDL–ApoA1 association.

Trust comment: Small randomized double-blind RCT (n=35) but very short duration (3 weeks) and modest sample size limit generalizability.

Study Details

PMID:25561147
Participants:35
Impact:significant decrease (sterol vs placebo)
Trust score:3/5

Randomized double-blind crossover: plant sterol–enriched spread lowered total and LDL cholesterol vs control without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover with 53 completers; robust design though modest sample size.

Study Details

PMID:11522112
Participants:53
Impact:-8.8% vs control (overall) ; -11.1% with fibrate subgroup; -7.7% without fibrates
Trust score:4/5

26-week open-label follow-up: daily plant sterol–enriched spread produced sustained LDL and total cholesterol reductions and increased circulating plant sterol markers.

Trust comment: Open-label follow-up with moderate sample (57) and some parents on statins; sustained effects but less controlled than blinded RCTs.

Study Details

PMID:15199384
Participants:57
Impact:-11.4% (children) ; -11.0% (parents)
Trust score:3/5

Large multicentre randomized trial: a portfolio diet including phytosterols reduced LDL-C substantially (~13%) and did not alter fat‑soluble vitamin levels after cholesterol adjustment.

Trust comment: Large randomized multicentre trial (n=351) with appropriate analyses and clinically relevant endpoints; some drop-outs and <100% adherence noted.

Study Details

PMID:25326876
Participants:351
Impact:decrease ~0.58–0.62 mmol/L (from ~4.42–4.50 to ~3.80–3.92) (~13% reduction)
Trust score:5/5

IPSS (prostate symptom score)

1 evidences

Double-blind RCT in men with mild–moderate BPH comparing β-sitosterol–enriched saw palmetto (VISPO), conventional saw palmetto, and placebo for 12 weeks; VISPO improved urinary symptoms, flow rate, residual volume, and several symptom/quality-of-life scores versus placebo.

Trust comment: Randomized double-blind placebo-controlled trial with 91 completers and objective urodynamic measures; moderate sample size.

Study Details

PMID:32620155
Participants:91
Impact:−3.18 points from baseline (VISPO, visit 3 change) compared to placebo
Trust score:4/5

Qmax (maximum urine flow)

1 evidences

Double-blind RCT in men with mild–moderate BPH comparing β-sitosterol–enriched saw palmetto (VISPO), conventional saw palmetto, and placebo for 12 weeks; VISPO improved urinary symptoms, flow rate, residual volume, and several symptom/quality-of-life scores versus placebo.

Trust comment: Randomized double-blind placebo-controlled trial with 91 completers and objective urodynamic measures; moderate sample size.

Study Details

PMID:32620155
Participants:91
Impact:+2.42 mL/s (VISPO change from baseline)
Trust score:4/5

Post-void residual urine volume

1 evidences

Double-blind RCT in men with mild–moderate BPH comparing β-sitosterol–enriched saw palmetto (VISPO), conventional saw palmetto, and placebo for 12 weeks; VISPO improved urinary symptoms, flow rate, residual volume, and several symptom/quality-of-life scores versus placebo.

Trust comment: Randomized double-blind placebo-controlled trial with 91 completers and objective urodynamic measures; moderate sample size.

Study Details

PMID:32620155
Participants:91
Impact:−12.76 mL (VISPO change from baseline)
Trust score:4/5

HbA1c

1 evidences

Patient-level pooled analysis of two dietary RCTs assessing adherence to the Portfolio Diet (which includes plant sterols) and change in HbA1c over 6 months; greater adherence was associated with modest reductions in HbA1c and improvements in lipid measures, while intake of plant sterols showed minimal change in this cohort.

Trust comment: Patient-level pooled analysis of two RCTs with 267 participants; secondary analysis with limited change in the plant‑sterols pillar, so indirect evidence for phytosterols.

Study Details

PMID:39275135
Participants:267
Impact:−0.04% per c-PDS point (≈ −0.3% HbA1c per 7.5‑point increase in Portfolio Diet Score); p=0.001
Trust score:3/5

Plant sterols intake (pillar)

1 evidences

Patient-level pooled analysis of two dietary RCTs assessing adherence to the Portfolio Diet (which includes plant sterols) and change in HbA1c over 6 months; greater adherence was associated with modest reductions in HbA1c and improvements in lipid measures, while intake of plant sterols showed minimal change in this cohort.

Trust comment: Patient-level pooled analysis of two RCTs with 267 participants; secondary analysis with limited change in the plant‑sterols pillar, so indirect evidence for phytosterols.

Study Details

PMID:39275135
Participants:267
Impact:No meaningful change/association (minimal change in plant sterols pillar)
Trust score:3/5

glucose

1 evidences

Phase I randomized placebo-controlled trial in healthy women testing an oral herbal supplement (contains phytosterols) for 3 months; overall well tolerated with no reported clinically significant adverse events.

Trust comment: Phase I randomized, double-blind safety trial with 55 participants; exploratory secondary findings and limited sample size.

Study Details

PMID:34379025
Participants:55
Impact:↑ glucose (1650 mg/day group; exploratory ANCOVA result; not clinically significant)
Trust score:3/5

Uric acid

1 evidences

Phase I randomized placebo-controlled trial in healthy women testing an oral herbal supplement (contains phytosterols) for 3 months; overall well tolerated with no reported clinically significant adverse events.

Trust comment: Phase I randomized, double-blind safety trial with 55 participants; exploratory secondary findings and limited sample size.

Study Details

PMID:34379025
Participants:55
Impact:↑ uric acid (1650 mg/day group; exploratory finding; not clinically significant)
Trust score:3/5

Systolic blood pressure

2 evidences

Phase I randomized placebo-controlled trial in healthy women testing an oral herbal supplement (contains phytosterols) for 3 months; overall well tolerated with no reported clinically significant adverse events.

Trust comment: Phase I randomized, double-blind safety trial with 55 participants; exploratory secondary findings and limited sample size.

Study Details

PMID:34379025
Participants:55
Impact:↑ systolic BP (3300 mg/day group; exploratory finding; not clinically significant)
Trust score:3/5

Eating cocoa-flavanol dark chocolate bars with added sterol esters (≈2.2 g/day) for 4 weeks reduced total and LDL cholesterol and lowered systolic blood pressure at 8 weeks.

Trust comment: Double-blind, placebo-controlled crossover with 49 participants; sterols combined with cocoa flavanols so effects are partly co-interventions.

Study Details

PMID:18356327
Participants:49
Impact:-5.8 mm Hg (at 8 weeks)
Trust score:4/5

Global menopausal symptom score

1 evidences

Pilot randomized phase II trial comparing two doses of a phytosterol-containing herbal supplement versus estrogen–progestogen therapy in postmenopausal women over 3 months; the herbal supplement groups showed larger short-term reductions in global, physical, and psychosocial menopausal symptom scores versus hormone therapy, while hormone therapy produced earlier improvement in vasomotor symptoms and greater changes in sex hormones and lipids.

Trust comment: Small single‑center phase II pilot (n=60 randomized, 54 completers); single‑blind and exploratory, so results are preliminary and need larger confirmation.

Study Details

PMID:37874969
Participants:54
Impact:Herbal vs EPT: −13.7 points (95% CI 6.9–20.4), P<0.001 (improvement)
Trust score:3/5

Physical symptom score

1 evidences

Pilot randomized phase II trial comparing two doses of a phytosterol-containing herbal supplement versus estrogen–progestogen therapy in postmenopausal women over 3 months; the herbal supplement groups showed larger short-term reductions in global, physical, and psychosocial menopausal symptom scores versus hormone therapy, while hormone therapy produced earlier improvement in vasomotor symptoms and greater changes in sex hormones and lipids.

Trust comment: Small single‑center phase II pilot (n=60 randomized, 54 completers); single‑blind and exploratory, so results are preliminary and need larger confirmation.

Study Details

PMID:37874969
Participants:54
Impact:Herbal vs EPT: −6.6 points (95% CI 1.6–11.5), P=0.002 (improvement)
Trust score:3/5

Psychosocial symptom score

1 evidences

Pilot randomized phase II trial comparing two doses of a phytosterol-containing herbal supplement versus estrogen–progestogen therapy in postmenopausal women over 3 months; the herbal supplement groups showed larger short-term reductions in global, physical, and psychosocial menopausal symptom scores versus hormone therapy, while hormone therapy produced earlier improvement in vasomotor symptoms and greater changes in sex hormones and lipids.

Trust comment: Small single‑center phase II pilot (n=60 randomized, 54 completers); single‑blind and exploratory, so results are preliminary and need larger confirmation.

Study Details

PMID:37874969
Participants:54
Impact:Herbal vs EPT: −3.8 points (95% CI 1.3–6.3), P<0.001 (improvement)
Trust score:3/5

total cholesterol

110 evidences

A nutraceutical drink containing red yeast rice lowered total and LDL cholesterol; the version without RYR showed no effect.

Trust comment: Double-blind RCT but multi-ingredient formulation (phytosterols present with others) and small completer N limit attribution to phytosterols alone.

Study Details

PMID:22385548
Participants:59
Impact:-13% at 4 weeks (-35 mg/dL); -14% at 8 weeks (-46 mg/dL)
Trust score:3/5

Mildly hypercholesterolemic adults who drank orange juice fortified with 2 g/day plant sterols for 8 weeks had clinically meaningful reductions in LDL and total cholesterol.

Trust comment: Randomized, placebo‑controlled trial with adequate sample for the intervention length and clear lipid endpoints, though short duration (8 weeks).

Study Details

PMID:14764424
Participants:72
Impact:decrease (−7.2%)
Trust score:4/5

Three-week double-blind RCT: daily 1.5 g phytosterols in low-fat milk reduced LDL-C and total cholesterol and modestly lowered diastolic blood pressure versus placebo.

Trust comment: Large, double-blind randomized placebo-controlled trial (n=221) with clear lipid endpoint reductions though short duration (3 weeks).

Study Details

PMID:28117400
Participants:221
Impact:−0.262 mmol/L (LS mean vs placebo)
Trust score:4/5

Eight-week double-blind RCT: soymilk with 2 g/day phytosterols (and 10 g/day inulin) twice daily produced significant LDL-C and total cholesterol reductions versus standard soymilk (effect apparent from week 2).

Trust comment: Large, well-blinded randomized controlled trial (240 randomized, 227 analyzed) showing clinically meaningful LDL-C and TC reductions over 8 weeks.

Study Details

PMID:26553006
Participants:227
Impact:Median −6.60% (study) vs −1.76% (control) (p<0.001)
Trust score:5/5

Softgel capsules delivering 2 g/day phytosterols for 4 weeks did not significantly lower total- or LDL-cholesterol compared with placebo in adults with mild–moderate hypercholesterolemia.

Trust comment: Double-blind randomized crossover in relevant clinical population; null result suggests capsule delivery may be less effective than food-based delivery of phytosterols.

Study Details

PMID:23623012
Participants:41
Impact:0.0 mmol/L (95% CI −0.3 to 0.2), not significant (P=0.74)
Trust score:4/5

Daily ~2.24 g plant sterols in fortified skim milk for 3-week periods in a double-blind crossover reduced total and LDL cholesterol versus control in young adults.

Trust comment: Randomized double-blind crossover (n=54) reporting clinically meaningful percent reductions in LDL and total cholesterol; methods summarized in Spanish but design appears appropriate.

Study Details

PMID:27513506
Participants:54
Impact:−9.73% (percent change from baseline vs control)
Trust score:4/5

Double-blind RCT of a combined product (red yeast rice, phytosterols, L-tyrosol) in 50 hypercholesterolemic subjects showing improved lipids, liver enzymes and endothelial function after 8 weeks.

Trust comment: Double-blind RCT supports moderate trust, but the intervention combined phytosterols with other active compounds so effects cannot be attributed to phytosterols alone.

Study Details

PMID:28687937
Participants:50
Impact:−16.3% active vs −9.9% placebo
Trust score:3/5

In HIV patients on HAART, phytosterol 2 g/day for 4 weeks modestly lowered LDL and total cholesterol; adding phytosterols to pravastatin did not further reduce LDL versus pravastatin alone.

Trust comment: Randomized cross-over with objective lipid measures but small sample and open-label design limit generalizability.

Study Details

PMID:26148680
Participants:33
Impact:-4.16%
Trust score:4/5

A multi-ingredient nutraceutical containing sterol esters/stanols improved fasting and post‑prandial lipid profile and reduced endothelial damage markers after 3 months versus placebo.

Trust comment: Randomized placebo-controlled trial with adequate size but uses a multi-component product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:29655700
Participants:80
Impact:decrease (p<0.05)
Trust score:3/5

In metabolic syndrome patients on a western diet, 4 g/day phytosterols for 2 months significantly reduced total cholesterol, LDL‑C, small dense LDL, apoB, and triglycerides.

Trust comment: Randomized, placebo-controlled trial with a substantial sample and clear lipid endpoints.

Study Details

PMID:21316934
Participants:108
Impact:-15.9%
Trust score:5/5

In 34 adults, bars containing plant sterols ± glucomannan showed that the sterol+glucomannan combination lowered total and LDL cholesterol; plant sterol alone had limited effect.

Trust comment: Randomized crossover in 34 subjects with clear lipid endpoints but small sample and effects largely driven by combination with glucomannan rather than plant sterol alone.

Study Details

PMID:16391591
Participants:34
Impact:−0.75 mmol/L (control 5.47 → combo 4.72; P<0.05)
Trust score:3/5

In 38 postmenopausal women, a 4-week milk drink with phytosterols plus β-cryptoxanthin lowered cholesterol and bone-turnover markers versus control.

Trust comment: Double-blind randomized crossover in 38 women with biochemical confirmation of phytosterol increases; moderate-quality, well-controlled study.

Study Details

PMID:24909799
Participants:38
Impact:decrease (significant vs control; P<0.05)
Trust score:4/5

In 90 randomized (85 completers) mildly hypercholesterolemic adults, an 8-week nutraceutical tablet containing phytosterols plus red yeast rice markedly lowered LDL-C and other lipids versus placebo.

Trust comment: Well-conducted double-blind RCT with 85 completers and significant lipid changes, but the product combined phytosterols with red yeast rice so effects are not attributable to phytosterols alone.

Study Details

PMID:33066334
Participants:85
Impact:LSM change −33.0 mg/dL (between-group difference −41.2 mg/dL; P<0.0001)
Trust score:4/5

Daily bread with 2.3 g phytosterols for 4 weeks lowered total and LDL cholesterol and reduced calculated CVD risk; HDL and TG unchanged.

Trust comment: Double-blind, placebo-controlled RCT with moderate sample and clear lipid endpoints.

Study Details

PMID:30990213
Participants:75
Impact:−7.6% (−0.52 mmol/L)
Trust score:4/5

A 3-month nutraceutical (contains 1.5 g phytosterols plus other agents) reduced total cholesterol, LDL-C and ApoB and lowered hs-CRP vs placebo.

Trust comment: Randomized, double-blind, placebo-controlled trial but intervention is a combination product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:31035469
Participants:40
Impact:−14.1% at 3 months
Trust score:4/5

Daily spread with ~2.2 g plant sterols for 6 weeks lowered fasting triglycerides and LDL-C in individuals with or at risk of T2DM (per-protocol analysis).

Trust comment: Large, randomized, double-blind, placebo-controlled study with predefined endpoints and appropriate analyses (per-protocol reported).

Study Details

PMID:29795368
Participants:138
Impact:−4.2% (−0.24 mmol/L)
Trust score:5/5

Softgel providing 1.8 g/day esterified plant sterols/stanols reduced LDL-C, non-HDL-C and total cholesterol versus placebo in adults with primary hypercholesterolemia.

Trust comment: Randomized, double-blind crossover replication study but small sample (n=30) limits precision.

Study Details

PMID:24287284
Participants:30
Impact:−3.5% (placebo-adjusted)
Trust score:4/5

Randomized double-blind crossover trial: 1.8 g/day non-esterified plant sterol/stanol tablets (6 weeks) added to TLC diet produced modest but significant reductions in atherogenic lipids.

Trust comment: Well-conducted randomized crossover trial with objective lipid endpoints, though sample size was modest.

Study Details

PMID:22087585
Participants:32
Impact:-2.8% (active vs control difference)
Trust score:4/5

In healthy Japanese volunteers, daily plant stanol ester spread modestly lowered total and LDL cholesterol and markedly reduced oxidized LDL over the trial period.

Trust comment: Randomized, placebo-controlled trial with 105 participants; short duration but well-controlled and directly tests plant stanol-containing product.

Study Details

PMID:12679174
Participants:105
Impact:-6.5% (2 g/d) and -5.5% (3 g/d)
Trust score:4/5

Crossover RCT: yogurt with 4 g/day plant stanol esters reduced total and LDL cholesterol over 4 weeks versus placebo without safety concerns.

Trust comment: Randomized double-blind placebo-controlled crossover with good compliance and clear lipid endpoints, though short duration (4 weeks per period).

Study Details

PMID:25099071
Participants:40
Impact:-15.6 mg/dL (-7.2%) vs placebo (p=0.001)
Trust score:4/5

Replacing usual cooking oil with plant sterol–enriched palm oil for 8 weeks lowered total and LDL cholesterol in hyperlipidemic adults; CRP showed a small rise vs baseline but no significant between-group change.

Trust comment: Double-blind randomized controlled trial (100 completers) with clear lipid outcomes; moderate sample and short duration limit long-term inference.

Study Details

PMID:39408337
Participants:100
Impact:-6.08% (vs control)
Trust score:4/5

Plant sterol ester–enriched low-fat milk and yoghurt reduced total and LDL cholesterol (~5–10%) in modestly hypercholesterolemic adults, with no effect on HDL or triglycerides.

Trust comment: Randomized crossover trials (total completers n≈79) showing consistent cholesterol reductions in modestly hypercholesterolemic subjects; small sample sizes per study phase.

Study Details

PMID:15316827
Participants:79
Impact:-6% to -8% (study 1 range)
Trust score:4/5

In type 2 diabetic patients, a phytosterol-enriched spread reduced total and LDL cholesterol (peak ~5–7% at 4 weeks) with effects attenuating over 12 weeks; small HDL increase and transient HbA1c reduction observed.

Trust comment: Randomized, double-blind controlled trial in 85 T2D patients with repeated measures showing modest lipid improvements but attenuation over time.

Study Details

PMID:12638032
Participants:85
Impact:-5.2% (at 4 weeks vs baseline; effect attenuated thereafter)
Trust score:4/5

Adults with mild–moderate hypercholesterolemia who ate low-fat foods providing 1.8 g/day phytosterols plus oat beta-glucan for 6 weeks had small but significant reductions in LDL and total cholesterol.

Trust comment: Randomized, double-blind, controlled trial with 112 participants showing modest LDL and total cholesterol lowering with phytosterol-containing foods.

Study Details

PMID:12612157
Participants:112
Impact:-2.3% vs +0.8% in control (P = 0.043)
Trust score:4/5

In HIV patients, ritonavir-boosted lopinavir increased total cholesterol and serum markers of cholesterol absorption (serum phytosterol ratios), indicating increased cholesterol absorption rather than synthesis.

Trust comment: Randomized clinical trial with objective biochemical markers showing increased serum phytosterol ratios and cholesterol with LPV/r; modest sample size.

Study Details

PMID:29683854
Participants:49
Impact:+1.0 ± 0.8 mmol/L in LPV/r group after 16 weeks
Trust score:4/5

Adults with low baseline lathosterol-to-cholesterol ratio (low endogenous synthesis) had larger reductions in total and LDL cholesterol when consuming 2 g/day plant sterols for 28 days, whereas high-synthesis individuals did not respond.

Trust comment: Randomized, single-blind crossover trial with biomarker-based stratification showing that baseline synthesis marker predicts response to plant sterols.

Study Details

PMID:25733626
Participants:63
Impact:-0.25 ± 0.05 mmol/L overall; -0.40 ± 0.07 mmol/L in low-synthesis subgroup (P < 0.0001)
Trust score:4/5

In healthy and mildly hypercholesterolemic adults, margarines enriched with plant sterols or sitostanol esters reduced total and LDL cholesterol by about 8–13% over ~3.5-week treatment periods without lowering HDL.

Trust comment: Randomized, double-blind Latin-square design with 95 completers demonstrating consistent LDL/TC lowering by sterol-enriched margarines.

Study Details

PMID:9630383
Participants:95
Impact:-8–13% (0.37–0.44 mmol/L) vs control
Trust score:4/5

In 157 adults with hypercholesterolemia consuming milk with 1.58 g/day phytosterol ester for 2 months, total cholesterol and LDL-C were significantly reduced vs normal milk and non-dairy groups.

Trust comment: Community RCT with moderate size and 2-month follow-up; results support LDL/TC lowering but some outcomes lacked detailed magnitudes in report.

Study Details

PMID:29903120
Participants:157
Impact:significant decrease vs control after 2 months (exact values not provided)
Trust score:3/5

In a controlled, crossover feeding study, adding plant sterols (3.3 g/day) reduced total and LDL cholesterol independently and additively with dietary fat reduction.

Trust comment: Double-blind, randomized, controlled crossover feeding study with precise interventions but small sample (n=22) limiting generalizability.

Study Details

PMID:19145455
Participants:22
Impact:-9.0% with plant sterols
Trust score:4/5

Controlled feeding trials showed that low- and moderate-fat plant sterol–fortified soymilks reduced total and LDL cholesterol (≈10–15%) versus 1% dairy milk; moderate-fat soymilk also reduced cholesterol absorption and triglycerides.

Trust comment: Well-controlled randomized crossover feeding trials with measured cholesterol kinetics and significant lipid effects, though two separate study groups (n=33 and n=23) and short duration.

Study Details

PMID:19843338
Participants:33
Impact:Low-fat soymilk: -10%; Moderate-fat soymilk: -12% vs 1% milk (29 days)
Trust score:4/5

In people with metabolic syndrome and high LDL, adding a soy/phytosterol medical food plus other plant compounds to a diet improved several cholesterol measures more than diet alone.

Trust comment: Randomized trial but small subgroup (n=24) and the intervention combined multiple compounds, limiting attribution specifically to phytosterols.

Study Details

PMID:21122628
Participants:24
Impact:decreased vs control (greater improvement in PED arm, P < 0.05)
Trust score:3/5

In statin-intolerant/unwilling adults, snack products containing a mix of cholesterol-lowering bioactives (including phytosterols) twice daily reduced LDL and total cholesterol over four weeks compared with control snacks.

Trust comment: Well-designed double-blind randomized crossover trial with clear numeric effects, though the product contained multiple active ingredients including phytosterols.

Study Details

PMID:35079806
Participants:54
Impact:-5.08 ± 1.12% vs control (P < 0.0001)
Trust score:5/5

In healthy middle-aged adults, daily plant stanol ester margarine reduced total cholesterol, LDL and triglycerides over 4 weeks of supplementation.

Trust comment: Randomized, double-blind but small sample and short duration limit generalizability.

Study Details

PMID:16546486
Participants:26
Impact:-10% (after 4 weeks MS)
Trust score:3/5

A spread containing milk peptides plus 2 g plant sterols daily modestly reduced home systolic blood pressure and lowered total and LDL cholesterol versus placebo.

Trust comment: Randomized double-blind design and moderate size, but effect attribution to plant sterols is confounded by co-administered bioactive peptides.

Study Details

PMID:22398753
Participants:104
Impact:-0.16 mmol/L (active vs +0.25 mmol/L placebo, p=0.005)
Trust score:3/5

In healthy volunteers consuming margarine with ~8.6 g/day phytosterols, total and LDL cholesterol fell substantially with no biologically important adverse effects on gut flora or female sex hormones.

Trust comment: Randomized, placebo-controlled dietary study under controlled conditions but small sample size; primary cholesterol effects robust.

Study Details

PMID:10654588
Participants:24
Impact:-18% (P<0.001)
Trust score:4/5

Daily intake of 1.6 g plant sterol esters in a spread for 1 year lowered total and LDL cholesterol modestly and was safe with no adverse hormone or clinical-chemical effects.

Trust comment: Large (n=185), randomized double-blind placebo-controlled 1-year trial with comprehensive safety measures.

Study Details

PMID:12771969
Participants:185
Impact:−4% (average over 1 year)
Trust score:5/5

In a controlled crossover trial in overweight hyperlipidemic men, phytosterols delivered in a functional oil reduced total and LDL cholesterol compared with olive oil.

Trust comment: Well-controlled crossover dietary trial but small sample (n=23) limiting generalizability.

Study Details

PMID:16483884
Participants:23
Impact:endpoint 4.71 vs 5.14 mmol/L (functional oil vs olive oil)
Trust score:3/5

Hypercholesterolemic men consuming 21 g/day of a plant sterol-enriched spread had modest reductions in total and LDL cholesterol; beta-carotene fell unless dietary fruit/veg advice was followed.

Trust comment: Randomized double-blind crossover study with 48 participants and relevant biochemical endpoints, though short intervention periods.

Study Details

PMID:15546434
Participants:48
Impact:-4.6%
Trust score:4/5

People eating bakery products delivering 3.2 g/day sterol esters for 8 weeks had lower total and LDL cholesterol without reductions in measured antioxidants.

Trust comment: Randomized double-blind placebo-controlled trial with direct sterol-enriched food intervention and clear biochemical outcomes, moderate sample size.

Study Details

PMID:14519792
Participants:57
Impact:-0.24 mmol/L (within-group) ; between-group difference 0.38 mmol/L (8.9%)
Trust score:4/5

A once-daily 2.5 g phytosterol drink reduced LDL-C, total cholesterol and ApoB-100 versus placebo; larger reductions seen in those with higher Mediterranean-diet adherence.

Trust comment: Double-blind, randomized, placebo-controlled crossover in humans with good completion and compliance, though short treatment periods (3 weeks) limit long-term conclusions.

Study Details

PMID:37960208
Participants:49
Impact:decrease (statistically significant); −12.3% ±8.6% in high adherers
Trust score:4/5

Randomized double-blind crossover: plant sterol–enriched spread lowered total and LDL cholesterol vs control without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover with 53 completers; robust design though modest sample size.

Study Details

PMID:11522112
Participants:53
Impact:-6.4% vs control
Trust score:4/5

26-week open-label follow-up: daily plant sterol–enriched spread produced sustained LDL and total cholesterol reductions and increased circulating plant sterol markers.

Trust comment: Open-label follow-up with moderate sample (57) and some parents on statins; sustained effects but less controlled than blinded RCTs.

Study Details

PMID:15199384
Participants:57
Impact:-9.1% (children and parents)
Trust score:3/5

In 84 sedentary adults with high cholesterol, 8 weeks of plant sterol supplementation lowered total cholesterol and absolute LDL and increased blood plant-sterol markers; combining sterols with exercise gave the best lipid changes.

Trust comment: Randomized, placebo-controlled 8‑week trial in humans with clear lipid outcomes, moderate sample size.

Study Details

PMID:15531661
Participants:84
Impact:-8.2%
Trust score:4/5

In ~84 mildly hypercholesterolemic patients, 2 g/day phytosterol-enriched low‑fat milk for 3 months reduced total and LDL cholesterol similarly across diets (LDL reductions ~7–9.6%) without consistent harm to carotenoids when combined with a healthy diet.

Trust comment: Randomized 3‑month parallel trial with clear lipid endpoints and moderate sample size; diet stratification well described.

Study Details

PMID:20456813
Participants:84
Impact:-5.5% to -6.7% after 3 months
Trust score:4/5

In 67 hypercholesterolemic adults, consuming cocoa snack bars with 1.5 g phytosterols twice daily for 6 weeks lowered total cholesterol (~4.7%) and LDL (~6%) and the total/HDL ratio, with a small reduction in lipid-adjusted beta‑carotene.

Trust comment: Randomized, double‑blind parallel trial with moderate sample size and clear lipid outcomes; short duration (6 weeks).

Study Details

PMID:17081832
Participants:67
Impact:-4.7% (6 weeks)
Trust score:4/5

Stanol ester intervention lowered cholesterol but did not affect serum 25‑hydroxyvitamin D; the study did not investigate vitamin D supplementation effects.

Trust comment: Large randomized controlled trial (n=318) with clear dose-response and clinical lipid endpoints; good reliability for cholesterol effects.

Study Details

PMID:10593347
Participants:318
Impact:-6.4% (US 3 g/d group)
Trust score:4/5

Yoghurt enriched with 1–2 g/d plant sterols lowered total and LDL cholesterol in a dose-dependent manner over the study periods; HDL and triglycerides were unchanged.

Trust comment: Randomized crossover design and significant lipid effects reported, but small sample and some outcomes not numerically detailed in abstract.

Study Details

PMID:11502237
Participants:30
Impact:decrease (dose-dependent; P<0.001)
Trust score:4/5

Postmenopausal women randomized to a plant‑based dietary program had higher circulating phytosterols (especially beta‑sitosterol) and larger total cholesterol reductions than controls.

Trust comment: Randomized dietary intervention with moderate sample size and meaningful biochemical outcomes, but non‑blinded and behavioral intervention may introduce bias.

Study Details

PMID:14652381
Participants:104
Impact:decrease (−14% intervention vs −4% control)
Trust score:3/5

Sitostanol-ester margarine (3 g/d) reduced total and LDL cholesterol in postmenopausal women, including when combined with statin therapy.

Trust comment: Randomized, double-blind crossover trial in clinical population with clear biochemical outcomes, but modest sample size.

Study Details

PMID:9416886
Participants:32
Impact:-13% (sitostanol margarine vs baseline), P < .05
Trust score:4/5

Cookies containing psyllium plus 2.6 g/day plant sterols for 4 weeks reduced total and LDL cholesterol and decreased apoB and numbers of atherogenic lipoprotein subfractions.

Trust comment: Randomized, double-blind crossover placebo-controlled study with clear lipid changes but modest sample size and short duration.

Study Details

PMID:16988115
Participants:33
Impact:From 5.65 to 5.28 mmol/L (−0.37 mmol/L), P < 0.01
Trust score:4/5

Daily phytosterol‑enriched margarine modestly lowered total and LDL cholesterol and raised HDL over 3 weeks, with larger LDL effects in higher‑intake subgroups.

Trust comment: Randomized, double-blind, placebo-controlled crossover with clear lipid outcomes and N=63 supports moderate confidence.

Study Details

PMID:11833047
Participants:63
Impact:-3.4%
Trust score:4/5

Daily rice‑bran plant sterols (2.1 g) lowered total and LDL cholesterol in healthy adults; triterpene alcohols showed no effect.

Trust comment: Crossover, double-blind study with N=60 and quantified lipid changes gives credible evidence for cholesterol lowering by plant sterols.

Study Details

PMID:11101479
Participants:60
Impact:-0.19 mmol/L (~-5%)
Trust score:4/5

Older hyperlipidemic adults consuming soy milk powder with phytosterol esters (≈2 g/day free phytosterols) for 6 months had reduced total and LDL cholesterol versus placebo.

Trust comment: Large randomized placebo-controlled trial (n=170) with clinically relevant lipid endpoints and 6-month follow-up.

Study Details

PMID:27440543
Participants:170
Impact:-9.3% (6 months vs control)
Trust score:4/5

An 8.8 g/day plant stanol ester intervention for 10 weeks lowered total and LDL cholesterol and decreased absorption markers while increasing synthesis markers; serum stanol levels rose modestly and normalized after washout.

Trust comment: Randomized double-blind parallel study (n=49) with clear biochemical endpoints; moderate sample size and 10-week duration.

Study Details

PMID:19774436
Participants:49
Impact:-12% (vs control)
Trust score:4/5

A 12-week low-GI diet including 30 g soy protein and 4 g phytosterols/day lowered cholesterol and triglycerides more than a standard diet in postmenopausal women.

Trust comment: Randomized 12-week trial with matched caloric/exercise controls and clear between-group lipid reductions, moderate sample size.

Study Details

PMID:16459222
Participants:53
Impact:-15.8%
Trust score:4/5

Six-week addition of 1.8 g soy stanol tablets to ongoing statin therapy produced additional ~9% LDL-C lowering versus placebo.

Trust comment: Double-blind placebo-controlled trial but small sample size limits generalizability.

Study Details

PMID:16442399
Participants:26
Impact:-12.9 mg/dl
Trust score:3/5

Daily soy drink with plant sterols for 8 weeks lowered LDL, total and non-HDL cholesterol in adults with moderate hypercholesterolemia.

Trust comment: Randomized double-blind placebo-controlled trial with clear LDL primary outcome but small sample and short duration (8 weeks).

Study Details

PMID:18837970
Participants:49
Impact:-3.91% at 8 weeks (P<0.01)
Trust score:4/5

In hypercholesterolemic children, sterol-ester spreads lowered plasma total and LDL cholesterol and increased red-cell plant sterol ratios when sterol esters were consumed.

Trust comment: Randomized double-blind crossover in children with small sample (n=23); design strong but limited power and pediatric-specific population.

Study Details

PMID:12756385
Participants:23
Impact:-6% with sterol ester
Trust score:3/5

In overweight adults on an 8-week calorie-restricted diet, adding plant sterols to rice bran led to larger reductions in total (and a trend for LDL) cholesterol versus rice bran alone.

Trust comment: Small randomized study (n=24) with short duration and weight-loss regimen that may confound lipid changes, but randomized design supports moderate confidence.

Study Details

PMID:24955613
Participants:24
Impact:additional decrease ~36 ± 25 mg/dL (RB+PS vs RB)
Trust score:3/5

In a randomized double-blind crossover (4-week PS phase), soy milk with phytosterols (1.6 g/day) modestly lowered total cholesterol (~-5.5%) and LDL-C (~-7.6%) and raised plasma campesterol and sitosterol, with changes in synthesis/absorption markers.

Trust comment: Well-controlled randomized crossover with objective biochemical endpoints (n=38) supports moderate-high confidence for short-term lipid effects.

Study Details

PMID:35397367
Participants:38
Impact:decrease ~5.5% (Control 261 → PS 244 mg/dL, p<0.001)
Trust score:4/5

Phytosterol-enriched chocolate (1.8 g/d) given for 4 weeks lowered total and LDL cholesterol without affecting HDL or triglycerides and raised markers of sterol absorption; no adverse effects.

Trust comment: Randomized double-blind placebo-controlled RCT in 70 hypercholesterolemic subjects with clear numeric lipid changes over 4 weeks.

Study Details

PMID:12425728
Participants:70
Impact:-6.4% (-0.44 mmol/L)
Trust score:4/5

Replacing butter with a polyunsaturated spread containing 2 g plant sterols daily in a reduced-fat diet reduced total and LDL cholesterol more than spread without sterols.

Trust comment: Randomized double-blind crossover dietary intervention in 50 participants with clear LDL/total cholesterol reductions.

Study Details

PMID:12548313
Participants:50
Impact:-8.9% (from 6.09 to 5.55 mmol/L)
Trust score:4/5

Both stanol-ester and sterol-ester margarines (~2 g/d) consumed for 4 weeks reduced total and LDL cholesterol similarly; sterol esters increased serum sitosterol and campesterol.

Trust comment: Randomized, double-blind Latin-square repeated measures design with 34 completers showing consistent cholesterol reductions.

Study Details

PMID:11002384
Participants:34
Impact:STAEST -9.2%; STEEST -7.3%
Trust score:4/5

Daily dressing containing 800 mg plant sterol for 12 weeks reduced total cholesterol, LDL-C and ApoB versus placebo with no adverse events reported.

Trust comment: Placebo-controlled double-blind trial in 59 subjects showing significant lipid reductions though numeric magnitudes not reported in abstract.

Study Details

PMID:18075221
Participants:59
Impact:decreased (significant at 8 and 12 weeks)
Trust score:4/5

6-week crossover in hypercholesterolemic adults: sterol-enriched yogurt and vine-ripened tomato sauce (high adherence) both reduced LDL-C; tomato sauce effects similar magnitude to sterol product in adherent subjects.

Trust comment: Crossover trial with 91 completers and dietetic supervision; partially unblinded due to different products but reasonable methodology.

Study Details

PMID:33407609
Participants:91
Impact:Yogurt −18 ±24 mg/dL; Tomato sauce-HA −11 ±18 mg/dL (both significant vs baseline)
Trust score:4/5

Adults with mild-moderate hypercholesterolemia consumed low-fat yoghurt with ~1.9 g/day plant stanols for 4 weeks and showed modest but significant LDL and total cholesterol reductions.

Trust comment: Well-designed randomized double-blind placebo-controlled trial (n=70) with clear lipid endpoints and statistically significant LDL lowering.

Study Details

PMID:23786762
Participants:70
Impact:-4.6%
Trust score:4/5

Mildly hypercholesterolemic Thais drank soy milk with 2 g/day plant stanols for 6 weeks and had substantial LDL and total cholesterol reductions; some fat-soluble carotenoids decreased.

Trust comment: Large (n=120), double-blind, placebo-controlled trial with clear clinically relevant LDL reductions and monitoring of vitamins; solid quality.

Study Details

PMID:22256472
Participants:120
Impact:-8.2%
Trust score:4/5

Volunteers consumed meat products enriched with plant sterols (different doses) and minerals in 3-week periods; higher-dose sterol meat reduced total cholesterol modestly.

Trust comment: Small single-blind randomized study (n=21 completed) showing modest total cholesterol reduction at higher sterol dose; limited power.

Study Details

PMID:15545047
Participants:21
Impact:-4.9% (p<0.05) during higher-dose period
Trust score:3/5

Taking encapsulated phytosterol esters for 12 weeks modestly lowered total and LDL cholesterol in people with high LDL.

Trust comment: Randomized, double-blind, placebo-controlled human trial with moderate sample size; results directly from phytosterol supplementation.

Study Details

PMID:17644340
Participants:54
Impact:-3.52% (mean change from baseline)
Trust score:4/5

Adding plant sterol esters to a reduced‑fat spread in a low‑fat diet lowered blood cholesterol and related lipids in adults with mild‑to‑moderate high cholesterol.

Trust comment: Randomized double‑blind parallel trial with clear lipid endpoints and per‑protocol effect sizes reported.

Study Details

PMID:11451715
Participants:224
Impact:−5.2% (1.1 g/d), −6.6% (2.2 g/d) (per‑protocol vs control)
Trust score:4/5

Different doses of plant stanol esters produced a dose‑dependent reduction in total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Single‑blind, within‑subject dose‑response in 22 participants; small sample but consistent dose effects.

Study Details

PMID:10736328
Participants:22
Impact:−2.8% (0.8 g/d), −6.8% (1.6 g/d), −10.3% (2.4 g/d), −11.3% (3.2 g/d) vs control
Trust score:3/5

Short preoperative consumption of stanol or sterol spreads lowered blood cholesterol in statin‑treated patients; stanols tended to reduce arterial plant sterols.

Trust comment: Randomized double‑blind study in a small, specialized perioperative statin‑treated population; limited generalizability.

Study Details

PMID:20096545
Participants:22
Impact:−17.2% (stanol ester) and −13.8% (sterol ester) vs baseline
Trust score:3/5

A spread with plant stanol esters (2 g/d) rapidly lowered cholesterol, hsCRP, and estimated cardiovascular risk compared with placebo.

Trust comment: Prospective randomized placebo‑controlled study with adequate sample size and clinically relevant endpoints.

Study Details

PMID:19939653
Participants:150
Impact:−14% (1 month)
Trust score:4/5

Daily consumption of 0.45 g/day phytosterol ester in oil lowered total cholesterol and certain atherogenic lipoproteins in men with higher baseline cholesterol.

Trust comment: Randomized, double-blind, placebo-controlled parallel trial (n=60) with clinically relevant lipid endpoints; quality high for dietary RCT.

Study Details

PMID:14505991
Participants:60
Impact:-10.3% (subjects with baseline >200 mg/dL) compared with control
Trust score:5/5

In hypercholesterolemic subjects, oat-bran produced a transient total cholesterol decrease but did not change serum plant sterol proportions or cholesterol synthesis precursors substantially.

Trust comment: Randomized dietary intervention (n=36) with post-hoc sterol analyses; modest size and some outcomes transient, limiting strength.

Study Details

PMID:9306087
Participants:36
Impact:transient decline in oat-bran group (no numeric % reported)
Trust score:3/5

Four weeks of yoghurt with 2 g plant stanol ester in obese women lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Single-blind, placebo-controlled with reasonable sample size (n=90) though short duration (4 weeks).

Study Details

PMID:25060157
Participants:90
Impact:decreased (significant, p<0.05)
Trust score:4/5

Fat-free foods containing soy stanol-lecithin reduced single-meal cholesterol absorption substantially and, over 4 weeks, lowered total cholesterol (~10%) and LDL (~14%).

Trust comment: Randomized, double-blind parallel trial with clear endpoints though modest sample size (n=24 for chronic outcomes).

Study Details

PMID:12728215
Participants:24
Impact:reduced by ~10.1% (chronic, n=24)
Trust score:4/5

In 309 Chinese adults, daily plant-sterol–enriched milk tea (1.5–2.3 g/day) for 5 weeks reduced total cholesterol modestly and produced a non-significant trend to lower LDL.

Trust comment: Large double-blind randomized controlled trial in humans with clear, directly measured lipid outcomes.

Study Details

PMID:17617940
Participants:309
Impact:-0.25 mmol/L (2.3 g/d, 95% CI 0.07–0.43, p=0.01); -0.23 mmol/L (1.5 g/d, p=0.01)
Trust score:5/5

In 68 healthy people, rye bread with 2–4 g/day plant sterols for short treatment periods lowered total and LDL cholesterol and improved apoB/apoA1 and cholesterol/HDL ratios without affecting fat‑soluble vitamins.

Trust comment: Double-blind dietary intervention in humans with objective lipid outcomes, though sample size moderate and treatment periods brief.

Study Details

PMID:21215605
Participants:68
Impact:-5.1% (2 g/d) and -6.5% (4 g/d)
Trust score:4/5

Eating cocoa-flavanol dark chocolate bars with added sterol esters (≈2.2 g/day) for 4 weeks reduced total and LDL cholesterol and lowered systolic blood pressure at 8 weeks.

Trust comment: Double-blind, placebo-controlled crossover with 49 participants; sterols combined with cocoa flavanols so effects are partly co-interventions.

Study Details

PMID:18356327
Participants:49
Impact:-2.0%
Trust score:4/5

In 29 rheumatoid arthritis patients, a strict uncooked vegan diet for 2–3 months lowered total and LDL cholesterol and changed plant sterol ratios (higher sitosterol:campesterol).

Trust comment: Randomized diet intervention in humans with clear biochemical outcomes but moderate sample size and indirect relation to supplement use.

Study Details

PMID:11242480
Participants:29
Impact:decrease (significant vs control)
Trust score:3/5

Low-fat margarines containing plant stanol esters added to a low-fat diet reduced total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Randomized, double-blind parallel trial in humans with clear lipid endpoints and statistically significant results; moderate sample size.

Study Details

PMID:10075323
Participants:55
Impact:WSEM: additional -10.6% vs control; VOSEM: additional -8.1% vs control
Trust score:4/5

Daily phytostanol softgels for 28 days lowered total and LDL cholesterol in adults with high cholesterol.

Trust comment: Randomized, double-blind, placebo-controlled human trial with clear percentage changes but small sample and short duration.

Study Details

PMID:17707978
Participants:30
Impact:-8%
Trust score:4/5

Daily plant stanol ester margarine reduced total and LDL cholesterol in healthy 6-year-old children regardless of gender or apoE phenotype.

Trust comment: Well-controlled, randomized cross-over study in children with consistent effects reported; moderate sample and robust design.

Study Details

PMID:12463311
Participants:81
Impact:~-6% (overall)
Trust score:4/5

In a 3‑month randomized study, adding phytosterols to canned tuna produced a significantly larger reduction in total and LDL cholesterol than tuna alone.

Trust comment: Large randomized single‑blind dietary intervention with consistent lipid outcomes, though exact effect sizes versus control not reported in the summary text.

Study Details

PMID:17594856
Participants:400
Impact:significant reduction in all groups; phytosterol group had greater reduction vs control (p<0.05)
Trust score:4/5

Milk powder with 2.5 g/day plant sterol esters lowered 'bad' (LDL) cholesterol in adults with high cholesterol over 6 weeks.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size (n=59).

Study Details

PMID:25327602
Participants:59
Impact:-8.00% vs placebo after 6 weeks (-0.51 mmol/L)
Trust score:4/5

Postmenopausal women who drank a beverage with 2 g/day plant sterols for 6 weeks had lower total and LDL cholesterol and changes in some sterol and cytokine markers.

Trust comment: Randomized double-blind crossover study measuring biochemical and inflammatory biomarkers in a defined cohort (n=38).

Study Details

PMID:30206618
Participants:38
Impact:-3.3% (220.0 to 212.9 mg/dL)
Trust score:4/5

A phytosterol-enriched rice bran oil spread consumed as part of the diet reduced total and LDL cholesterol in mildly hypercholesterolaemic adults.

Trust comment: Randomized double-blind crossover trial with adequate sample (n=80) and clear lipid outcomes.

Study Details

PMID:21320365
Participants:80
Impact:-4.4% vs standard spread
Trust score:4/5

Plant stanol (2.5 g/day) margarine for 3 weeks lowered total and LDL cholesterol and reduced triglycerides especially in subjects with high baseline TAG.

Trust comment: Randomized placebo-controlled study but small sample (n=28) and subgroup effects reported.

Study Details

PMID:19904567
Participants:28
Impact:-6.7%
Trust score:3/5

Ten-day administration of tall oil phytosterols lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Randomized crossover with mechanistic measures but short duration and small sample (n=22).

Study Details

PMID:9627377
Participants:22
Impact:≈-6% (5.0 to 4.7 mmol/L)
Trust score:3/5

Low‑fat margarine and milk providing 2.3 g/day plant sterols reduced total and LDL cholesterol in mildly hypercholesterolemic adults.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover with 46 completers; clinically relevant endpoints and clear percent changes reported.

Study Details

PMID:17719702
Participants:46
Impact:-5.5%
Trust score:4/5

Adding 5.1 g/day plant stanol spread to stable statin therapy further lowered total and LDL cholesterol compared with placebo spread.

Trust comment: Randomized, double‑blind, placebo‑controlled trial with 167 participants on stable statin therapy; robust, clinically relevant reductions reported.

Study Details

PMID:10867091
Participants:167
Impact:-12% (active) vs -5% (placebo)
Trust score:4/5

Low‑fat foods enriched with 1.25–5.0 g/day natural plant sterols reduced total and LDL cholesterol in mildly–moderately hypercholesterolemic adults.

Trust comment: 15‑week randomized, double‑blind, placebo‑controlled feeding trial with 71 completers; good duration and dietary control.

Study Details

PMID:11703963
Participants:71
Impact:-8% (active) vs -3% (placebo)
Trust score:4/5

Study tested plant sterol–fortified spreads on cholesterol; measured 25-OH-vitamin D and found no change, but the intervention was not vitamin D supplementation.

Trust comment: Randomized, double‑blind, placebo‑controlled design with 100 subjects and dose‑response data; credible and informative.

Study Details

PMID:10334658
Participants:100
Impact:-0.26 to -0.35 mmol/L (~4.9–6.8%)
Trust score:4/5

Adding 2 g/day plant sterol–enriched milk to a healthy diet reduced total and LDL cholesterol without worsening overall antioxidant status, though one carotenoid (cryptoxanthin) fell.

Trust comment: Randomized parallel trial with defined interventions and measured biochemical outcomes; moderate quality.

Study Details

PMID:19889524
Participants:40
Impact:-6.4%
Trust score:4/5

Six weeks of daily phytosterol-enriched low-fat fermented milk lowered total and LDL cholesterol and reduced a plasma isoprostane marker of oxidative burden.

Trust comment: Multicenter randomized double-blind design with clear lipid and oxidative marker changes over 6 weeks.

Study Details

PMID:18762410
Participants:116
Impact:-~12.3% (from 263.5 to 231.0 mg/dL)
Trust score:4/5

Three months of 2 g/day phytosterol plus healthy diet lowered total and LDL cholesterol and improved apolipoprotein ratio, with no change in LDL particle size.

Trust comment: Randomized parallel trial with adequate sample and clear lipid outcome reporting.

Study Details

PMID:21048770
Participants:75
Impact:-5.1%
Trust score:4/5

Meta-analysis of four parallel double-blind substudies (5-week each) found low-fat milk products with 2 g/day stanols modestly lowered total and LDL cholesterol.

Trust comment: Pooled randomized double-blind substudies with moderate sample but unpublished substudies and short interventions reduce confidence.

Study Details

PMID:17225918
Participants:199
Impact:-3.8% (pooled treatment difference; 95% CI -6.0 to -1.7)
Trust score:3/5

Replacing part of daily fat with sitostanol-ester margarine for one year lowered total and LDL cholesterol and was well tolerated.

Trust comment: One-year randomized double-blind trial (n=153) with clear significant cholesterol reductions and good design.

Study Details

PMID:7566021
Participants:153
Impact:-10.2% (mean reduction in sitostanol group; difference vs control -24 mg/dL)
Trust score:5/5

Daily intake of a plant sterol–enriched spread for 4 weeks lowered total and LDL cholesterol and apolipoprotein B without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover (n=42) showing consistent lipid-lowering effects with plant sterol intake.

Study Details

PMID:12003257
Participants:42
Impact:-7% (−18 mg/dL)
Trust score:5/5

Checklist: - Confirm human RCT testing plant stanol (phytosterol) effect in children; - Extract main measured outcomes (total cholesterol, LDL-C, beta-carotene/LDL ratio); - Record participant count and numerical changes; assess study quality quickly. Simple summary: In a double-blind crossover trial in 6-year-old children, replacing fat with plant stanol–enriched margarine slightly lowered total and LDL cholesterol but reduced beta-carotene/LDL ratio.

Trust comment: Well-conducted double-blind randomized crossover trial in children with intention-to-treat analysis and clear numerical outcomes.

Study Details

PMID:10753249
Participants:81
Impact:-5.4%
Trust score:4/5

Checklist: - Confirm human semirandomized double-blind crossover trial testing free plant sterols with high vs low dietary cholesterol; - Extract main outcomes (LDL-C, total cholesterol, plasma beta-sitosterol); - Note participant count and interaction results. Simple summary: In a 22-person crossover trial, plant sterol supplementation lowered cholesterol independent of dietary cholesterol level and increased plasma beta-sitosterol.

Trust comment: Small, controlled crossover RCT with clear design but limited sample size and incomplete numerical details in the provided text.

Study Details

PMID:18249205
Participants:22
Impact:Decrease with PS supplementation (not quantified here)
Trust score:3/5

Phytosterol-enriched milk (2 g/day) reduced cholesterol measures in non-MetS patients (LDL ~-10.5%) but produced little or no benefit in MetS patients.

Trust comment: Randomized parallel trial but small subgroup sizes and limited power; findings plausible but sample-limited.

Study Details

PMID:21489663
Participants:48
Impact:-6.9% (non-MetS); no meaningful change (MetS)
Trust score:3/5

Daily ingestion of 2 g plant stanols lowered LDL-C (~9–10%) and ApoB (~5–9%) in Japanese subjects; response was not influenced by ApoE phenotype.

Trust comment: Randomized, placebo-controlled trial with >100 subjects and clear lipid endpoints; good quality for dietary intervention.

Study Details

PMID:12093429
Participants:105
Impact:reduced (statistically significant; % not broken down by genotype)
Trust score:4/5

In patients undergoing carotid surgery, cholestyramine plus sitosterol lowered LDL-C less than atorvastatin and plaques showed higher macrophage content versus high‑dose statin.

Trust comment: Randomized trial with histological endpoints in 60 patients; well-conducted but small and effects were influenced by differences in LDL‑C lowering.

Study Details

PMID:20413736
Participants:60
Impact:decrease, but smaller magnitude vs atorvastatin groups
Trust score:4/5

In 72 healthy adults, a reduced-calorie orange juice with plant sterols (2 g/day) for 8 weeks lowered LDL (~9.4%), total cholesterol (~5%), and CRP (~12%) and increased HDL.

Trust comment: Randomized trial of moderate size with clear lipid and CRP changes; 8-week duration limits long-term inference.

Study Details

PMID:17023701
Participants:72
Impact:−5% (P<0.01 vs baseline/placebo)
Trust score:4/5

Children with familial hypercholesterolemia given plant sterols had lower cholesterol but no short-term improvement in blood vessel function.

Trust comment: Double-blind crossover trial in 41 children with clear lipid outcomes but short treatment period and pediatric-specific sample.

Study Details

PMID:12971422
Participants:41
Impact:-11%
Trust score:4/5

- Checklist: - Confirm human study and outcomes (lipids, endothelial function). - Extract participant count and main outcomes (TC, LDL-C, FMD). - Report numeric changes, assess quality. Children with familial high cholesterol took yogurt with 2.0 g plant stanols daily; their LDL and total cholesterol fell but blood vessel function (FMD) did not improve.

Trust comment: Double-blind crossover RCT in children with clear numeric lipid and FMD results; moderate sample size.

Study Details

PMID:16647412
Participants:42
Impact:-7.5%
Trust score:4/5

In a 4-week crossover double-blind study, margarine with phytosterol esters lowered blood cholesterol levels, with genotype affecting the size of the effect.

Trust comment: Well-conducted double-blind crossover RCT with moderate sample and genotype stratification, providing reliable lipid outcome data.

Study Details

PMID:12771320
Participants:60
Impact:-10% (overall); -7.2% (CETP II phenotype)
Trust score:4/5

Five-week randomized double-blind trial showed cheese with 2 g/day plant stanols lowered total and LDL cholesterol compared with control cheese.

Trust comment: Randomized double-blind parallel study with full completion and clear lipid endpoints; moderate sample gives reliable effect estimates.

Study Details

PMID:16721398
Participants:67
Impact:-5.8% (-0.32 mmol/L)
Trust score:4/5

Diastolic blood pressure

2 evidences

Three-week double-blind RCT: daily 1.5 g phytosterols in low-fat milk reduced LDL-C and total cholesterol and modestly lowered diastolic blood pressure versus placebo.

Trust comment: Large, double-blind randomized placebo-controlled trial (n=221) with clear lipid endpoint reductions though short duration (3 weeks).

Study Details

PMID:28117400
Participants:221
Impact:−1.93 mmHg (vs placebo)
Trust score:4/5

Omega-3 plant sterol esters reduced triglycerides and modestly lowered diastolic BP and hsCRP but did not change LDL in mixed hyperlipidemic patients.

Trust comment: Randomized, double-blind trial with meaningful findings but substantial dropouts (24/91) and mixed intervention limits certainty.

Study Details

PMID:20617456
Participants:67
Impact:-7% (−5.9 mmHg)
Trust score:3/5

Other lipid markers and oxidative stress markers

1 evidences

Four-month double-blind RCT of a multi-ingredient supplement (includes 1.8 g phytosterols/day) found no significant change in LDL-C or other lipid and oxidative markers versus placebo.

Trust comment: Well-conducted double-blind RCT but small sample (n=42) and multi-ingredient formulation prevents isolating phytosterol-specific effects.

Study Details

PMID:40147213
Participants:42
Impact:No significant differences between groups
Trust score:3/5

Total cholesterol, HDL-C, triglycerides

1 evidences

Three-month double-blind RCT of a monacolin K–free nutraceutical (contains phytosterols 400 mg per capsule, two capsules/day) found no significant changes in LDL-C, total cholesterol, triglycerides or inflammatory markers versus placebo.

Trust comment: Randomized double-blind RCT with moderate sample size (125 randomized, 118 completed) but low phytosterol dose in the combination and multi-ingredient confounding limit attribution.

Study Details

PMID:35889769
Participants:118
Impact:No significant changes
Trust score:3/5

Inflammatory markers (hs-CRP, IL-32, IL-38, selected miRs)

1 evidences

Three-month double-blind RCT of a monacolin K–free nutraceutical (contains phytosterols 400 mg per capsule, two capsules/day) found no significant changes in LDL-C, total cholesterol, triglycerides or inflammatory markers versus placebo.

Trust comment: Randomized double-blind RCT with moderate sample size (125 randomized, 118 completed) but low phytosterol dose in the combination and multi-ingredient confounding limit attribution.

Study Details

PMID:35889769
Participants:118
Impact:No significant changes
Trust score:3/5

Classical lipid profile (TC, LDL-C, HDL-C, TG)

1 evidences

Pilot randomized crossover study in adults with dyslipidemia: adding phytosterol capsules to diet produced no significant changes in classical lipid profile or LDL particle quality versus diet alone; a trend toward lower intermediate HDL-7 was observed.

Trust comment: Pilot, open-label crossover with very small completed sample (n=23); methods novel but limited power to detect effects on subfractions or particle quality.

Study Details

PMID:38750162
Participants:23
Impact:No significant difference diet vs diet+phytosterol (primary comparison)
Trust score:3/5

HDL-7 (intermediate HDL subfraction)

1 evidences

Pilot randomized crossover study in adults with dyslipidemia: adding phytosterol capsules to diet produced no significant changes in classical lipid profile or LDL particle quality versus diet alone; a trend toward lower intermediate HDL-7 was observed.

Trust comment: Pilot, open-label crossover with very small completed sample (n=23); methods novel but limited power to detect effects on subfractions or particle quality.

Study Details

PMID:38750162
Participants:23
Impact:Trend to decrease with phytosterol (p≈0.05)
Trust score:3/5

LDL particle quality/oxidation (Z-scan, UV-vis)

1 evidences

Pilot randomized crossover study in adults with dyslipidemia: adding phytosterol capsules to diet produced no significant changes in classical lipid profile or LDL particle quality versus diet alone; a trend toward lower intermediate HDL-7 was observed.

Trust comment: Pilot, open-label crossover with very small completed sample (n=23); methods novel but limited power to detect effects on subfractions or particle quality.

Study Details

PMID:38750162
Participants:23
Impact:No significant change
Trust score:3/5

Triglycerides and HDL-C

1 evidences

Eight-week double-blind RCT: soymilk with 2 g/day phytosterols (and 10 g/day inulin) twice daily produced significant LDL-C and total cholesterol reductions versus standard soymilk (effect apparent from week 2).

Trust comment: Large, well-blinded randomized controlled trial (240 randomized, 227 analyzed) showing clinically meaningful LDL-C and TC reductions over 8 weeks.

Study Details

PMID:26553006
Participants:227
Impact:No significant change vs control
Trust score:5/5

LDL-C (phytosterol add-on to RYR)

1 evidences

In patients taking red yeast rice, adding phytosterol tablets (900 mg twice daily) did not further reduce LDL-C over 12–52 weeks compared with placebo; lifestyle change produced additional LDL-C and weight reductions.

Trust comment: Randomized, double-blind placebo-controlled trial (n=187) but all participants received LDL-lowering red yeast rice, limiting ability to detect incremental phytosterol effects.

Study Details

PMID:23816039
Participants:187
Impact:No significant additional LDL-C reduction at 12, 24, or 52 weeks (P>.05)
Trust score:4/5

Lifestyle change program

1 evidences

In patients taking red yeast rice, adding phytosterol tablets (900 mg twice daily) did not further reduce LDL-C over 12–52 weeks compared with placebo; lifestyle change produced additional LDL-C and weight reductions.

Trust comment: Randomized, double-blind placebo-controlled trial (n=187) but all participants received LDL-lowering red yeast rice, limiting ability to detect incremental phytosterol effects.

Study Details

PMID:23816039
Participants:187
Impact:Greater LDL-C reductions at 12 and 24 weeks (e.g., −51 vs −42 mg/dL at 12 weeks) and more weight loss over 1 year (−2.3 vs −0.3 kg)
Trust score:4/5

HDL cholesterol

23 evidences

A nutraceutical drink containing red yeast rice lowered total and LDL cholesterol; the version without RYR showed no effect.

Trust comment: Double-blind RCT but multi-ingredient formulation (phytosterols present with others) and small completer N limit attribution to phytosterols alone.

Study Details

PMID:22385548
Participants:59
Impact:no significant change (nutraceutical with RYR)
Trust score:3/5

In 134 adults with impaired glucose regulation, 12-week plant sterol (1.7 g/day) supplementation decreased triglycerides and hs-CRP; combined plant sterol+omega‑3 produced additional benefits on HDL and glucose/insulin indices.

Trust comment: Randomized, double-blind, placebo-controlled 2×2 factorial trial with 134 participants and multiple metabolic endpoints; reasonably powered and well-reported.

Study Details

PMID:31043161
Participants:134
Impact:increase with combined PS+omega-3 versus placebo (P<0.05; small absolute change)
Trust score:4/5

Daily bread with 2.3 g phytosterols for 4 weeks lowered total and LDL cholesterol and reduced calculated CVD risk; HDL and TG unchanged.

Trust comment: Double-blind, placebo-controlled RCT with moderate sample and clear lipid endpoints.

Study Details

PMID:30990213
Participants:75
Impact:no change
Trust score:4/5

Daily spread with ~2.2 g plant sterols for 6 weeks lowered fasting triglycerides and LDL-C in individuals with or at risk of T2DM (per-protocol analysis).

Trust comment: Large, randomized, double-blind, placebo-controlled study with predefined endpoints and appropriate analyses (per-protocol reported).

Study Details

PMID:29795368
Participants:138
Impact:no change
Trust score:5/5

Softgel providing 1.8 g/day esterified plant sterols/stanols reduced LDL-C, non-HDL-C and total cholesterol versus placebo in adults with primary hypercholesterolemia.

Trust comment: Randomized, double-blind crossover replication study but small sample (n=30) limits precision.

Study Details

PMID:24287284
Participants:30
Impact:no change
Trust score:4/5

In postmenopausal women, different stanol-enriched margarines and butters (≈2.4–3.2 g/d stanols) reduced LDL cholesterol and LDL/HDL ratio and modestly increased HDL, while some carotenoids decreased.

Trust comment: Controlled double-blind crossover study with direct measured lipid effects but small sample of 23 postmenopausal women limits generalizability.

Study Details

PMID:10337856
Participants:23
Impact:+5–6% vs baseline (P < 0.05)
Trust score:4/5

During active weight loss phytosterol (campesterol) levels rose and synthesis marker (lanosterol) fell, with rebounds over long-term follow-up and an overall increase from baseline at 24 months.

Trust comment: Well-characterized randomized dietary trial with moderate sample size and repeated measures, providing reliable metabolic data.

Study Details

PMID:21940598
Participants:90
Impact:+17.0% (over study, P<0.001)
Trust score:4/5

In a controlled crossover trial in overweight hyperlipidemic men, phytosterols delivered in a functional oil reduced total and LDL cholesterol compared with olive oil.

Trust comment: Well-controlled crossover dietary trial but small sample (n=23) limiting generalizability.

Study Details

PMID:16483884
Participants:23
Impact:no significant change
Trust score:3/5

Daily intake of 2 g plant sterols reduced LDL-C and triglycerides in mildly hypercholesterolaemic adults; fish oil mainly reduced TAG and increased HDL; combination lowered TAG without interaction on cholesterol.

Trust comment: Large (n=200), double-blind randomized 2x2 factorial trial with clear effects on lipids but short duration (4 weeks).

Study Details

PMID:19296875
Participants:200
Impact:No significant change with plant sterols (fish oil increased HDL by 5.4%)
Trust score:4/5

Daily phytosterol‑enriched margarine modestly lowered total and LDL cholesterol and raised HDL over 3 weeks, with larger LDL effects in higher‑intake subgroups.

Trust comment: Randomized, double-blind, placebo-controlled crossover with clear lipid outcomes and N=63 supports moderate confidence.

Study Details

PMID:11833047
Participants:63
Impact:+3.4%
Trust score:4/5

Daily rice‑bran plant sterols (2.1 g) lowered total and LDL cholesterol in healthy adults; triterpene alcohols showed no effect.

Trust comment: Crossover, double-blind study with N=60 and quantified lipid changes gives credible evidence for cholesterol lowering by plant sterols.

Study Details

PMID:11101479
Participants:60
Impact:no significant change
Trust score:4/5

Phytosterol-enriched chocolate (1.8 g/d) given for 4 weeks lowered total and LDL cholesterol without affecting HDL or triglycerides and raised markers of sterol absorption; no adverse effects.

Trust comment: Randomized double-blind placebo-controlled RCT in 70 hypercholesterolemic subjects with clear numeric lipid changes over 4 weeks.

Study Details

PMID:12425728
Participants:70
Impact:no change
Trust score:4/5

Replacing butter with a polyunsaturated spread containing 2 g plant sterols daily in a reduced-fat diet reduced total and LDL cholesterol more than spread without sterols.

Trust comment: Randomized double-blind crossover dietary intervention in 50 participants with clear LDL/total cholesterol reductions.

Study Details

PMID:12548313
Participants:50
Impact:no change
Trust score:4/5

Four weeks of yoghurt with 2 g plant stanol ester in obese women lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Single-blind, placebo-controlled with reasonable sample size (n=90) though short duration (4 weeks).

Study Details

PMID:25060157
Participants:90
Impact:no change
Trust score:4/5

In a 9-week double-blind crossover (n=76), a spread enriched with 0.8 g/day free soybean-derived plant sterols lowered total and LDL cholesterol modestly; another sterol source did not lower cholesterol.

Trust comment: Balanced double-blind crossover RCT (n=76) showing modest, statistically significant LDL lowering with low-dose free plant sterols.

Study Details

PMID:10655976
Participants:76
Impact:no change
Trust score:4/5

Consuming low-fat dairy products with ~2 g/day plant sterols for 6 weeks reduced total and LDL cholesterol without lowering fat-soluble vitamin levels.

Trust comment: Large, multi-site double-blind randomized trial with clear, statistically significant lipid changes and safety measures reported.

Study Details

PMID:16404415
Participants:164
Impact:no change
Trust score:5/5

Daily low-fat yoghurt containing plant stanol esters lowered LDL cholesterol within 1 week; some fat-soluble antioxidants changed.

Trust comment: Randomized parallel study with clear lipid endpoints but modest sample size and short duration (4 weeks).

Study Details

PMID:11755939
Participants:60
Impact:no change
Trust score:4/5

Daily spreads with microcrystalline plant sterols (1.5–3.0 g/day) lowered total and LDL cholesterol over 6 months with no apparent adverse effects on fat‑soluble vitamins.

Trust comment: Large double-blind, randomized, placebo-controlled 6‑month trial with clinically relevant endpoints and adequate sample size.

Study Details

PMID:11518201
Participants:155
Impact:no change
Trust score:5/5

Milk powder with 2.5 g/day plant sterol esters lowered 'bad' (LDL) cholesterol in adults with high cholesterol over 6 weeks.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size (n=59).

Study Details

PMID:25327602
Participants:59
Impact:no change
Trust score:4/5

Ten-day administration of tall oil phytosterols lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Randomized crossover with mechanistic measures but short duration and small sample (n=22).

Study Details

PMID:9627377
Participants:22
Impact:no change
Trust score:3/5

Consuming 2.5 g plant stanols daily (either once or divided) lowered LDL cholesterol; HDL and triglycerides were unchanged.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover (39 subjects) with clear LDL effect and appropriate control periods.

Study Details

PMID:11002377
Participants:39
Impact:No change
Trust score:4/5

- Checklist: - Confirm randomized crossover feeding trial and main outcomes (LDL-C, HDL-C). - Extract completed participant count and LDL/HDL changes. - Provide quality judgement. In a controlled crossover feeding study, replacing part of the diet with a plant-sterol–enriched spread lowered LDL cholesterol more than replacing the spread with carbohydrate.

Trust comment: Randomized, controlled crossover feeding study with all foods provided; small sample but strong internal control.

Study Details

PMID:16216719
Participants:29
Impact:no meaningful change on plant sterol diet (CHO diet decreased HDL by −0.11 mmol/L)
Trust score:4/5

- Checklist: - Confirm randomized crossover single-blind human trial and primary outcomes (lipids). - Extract participant count and main lipid changes. - Note study limitations (single morning dose administration). In adults with mild-to-moderate hypercholesterolemia, single morning doses of several plant sterol preparations for 29 days did not lower total or LDL cholesterol but were associated with an approximate 8% increase in HDL.

Trust comment: Randomized crossover single-blind trial with small sample and unconventional single-dose-with-breakfast design reducing generalizability.

Study Details

PMID:16549466
Participants:30
Impact:+~8%
Trust score:3/5

LDL cholesterol

164 evidences

A nutraceutical drink containing red yeast rice lowered total and LDL cholesterol; the version without RYR showed no effect.

Trust comment: Double-blind RCT but multi-ingredient formulation (phytosterols present with others) and small completer N limit attribution to phytosterols alone.

Study Details

PMID:22385548
Participants:59
Impact:-17.1% at 4 weeks (-28 mg/dL); -17.8% at 8 weeks (-30 mg/dL)
Trust score:3/5

In patients with severe aortic stenosis consuming 2 g/day plant stanols or sterols until valve replacement (~2.6 months), LDL fell but valve sterol content, structure, and inflammation were unchanged.

Trust comment: Randomized, double-blind controlled intervention but small sample and short exposure before surgery limit generalizability.

Study Details

PMID:25614126
Participants:36
Impact:decrease 16% (plant stanol, p<0.05); decrease 11% (plant sterol, not significant)
Trust score:3/5

Mildly hypercholesterolemic adults who drank orange juice fortified with 2 g/day plant sterols for 8 weeks had clinically meaningful reductions in LDL and total cholesterol.

Trust comment: Randomized, placebo‑controlled trial with adequate sample for the intervention length and clear lipid endpoints, though short duration (8 weeks).

Study Details

PMID:14764424
Participants:72
Impact:decrease (−12.4%)
Trust score:4/5

2 g/day plant sterols for 28 days reduced LDL cholesterol by ~0.30 mmol/L; reductions were similar across APOE/CYP7A1 genosets (no genotype interaction).

Trust comment: Double-blind, randomized, placebo-controlled crossover with genotype-based recruitment; under-recruited but analysis shows consistent LDL lowering and no genotype effect.

Study Details

PMID:34791009
Participants:42
Impact:−0.30 mmol/L (mean reduction; approx −0.29 to −0.36 mmol/L across genosets; Poverall=0.0002)
Trust score:4/5

Softgel capsules delivering 2 g/day phytosterols for 4 weeks did not significantly lower total- or LDL-cholesterol compared with placebo in adults with mild–moderate hypercholesterolemia.

Trust comment: Double-blind randomized crossover in relevant clinical population; null result suggests capsule delivery may be less effective than food-based delivery of phytosterols.

Study Details

PMID:23623012
Participants:41
Impact:−0.1 mmol/L (95% CI −0.3 to 0.1), not significant (P=0.32)
Trust score:4/5

Daily ~2.24 g plant sterols in fortified skim milk for 3-week periods in a double-blind crossover reduced total and LDL cholesterol versus control in young adults.

Trust comment: Randomized double-blind crossover (n=54) reporting clinically meaningful percent reductions in LDL and total cholesterol; methods summarized in Spanish but design appears appropriate.

Study Details

PMID:27513506
Participants:54
Impact:−12.5% (percent change from baseline vs control)
Trust score:4/5

Phytosterols (2 g/day) lowered total and LDL cholesterol modestly; combining phytosterols with curcumin produced larger reductions over 4 weeks.

Trust comment: Double-blind, randomized, placebo-controlled factorial RCT with clear lipid outcomes though short duration (4 weeks).

Study Details

PMID:29291429
Participants:70
Impact:PS −8.1% from baseline; PS+curcumin −14.4% (greater reduction)
Trust score:4/5

Daily soya drink fortified with 2 g phytosterols for 3 weeks produced a small but significant reduction in LDL-cholesterol versus placebo.

Trust comment: Large, double-blind RCT in a relevant population with clear LDL outcome though short duration (3 weeks).

Study Details

PMID:31642984
Participants:159
Impact:mean LDL −5.96% from baseline; −4.70% vs placebo (p=0.028)
Trust score:4/5

Double-blind RCT of a combined product (red yeast rice, phytosterols, L-tyrosol) in 50 hypercholesterolemic subjects showing improved lipids, liver enzymes and endothelial function after 8 weeks.

Trust comment: Double-blind RCT supports moderate trust, but the intervention combined phytosterols with other active compounds so effects cannot be attributed to phytosterols alone.

Study Details

PMID:28687937
Participants:50
Impact:−23.4% active vs −13.2% placebo
Trust score:3/5

In 34 adults, bars containing plant sterols ± glucomannan showed that the sterol+glucomannan combination lowered total and LDL cholesterol; plant sterol alone had limited effect.

Trust comment: Randomized crossover in 34 subjects with clear lipid endpoints but small sample and effects largely driven by combination with glucomannan rather than plant sterol alone.

Study Details

PMID:16391591
Participants:34
Impact:−0.65 mmol/L for combination (control 3.60 → combo 2.95; P<0.05); glucomannan alone −0.44 mmol/L (3.60 → 3.16; P<0.05)
Trust score:3/5

In 38 postmenopausal women, a 4-week milk drink with phytosterols plus β-cryptoxanthin lowered cholesterol and bone-turnover markers versus control.

Trust comment: Double-blind randomized crossover in 38 women with biochemical confirmation of phytosterol increases; moderate-quality, well-controlled study.

Study Details

PMID:24909799
Participants:38
Impact:decrease (significant vs control; P<0.05)
Trust score:4/5

In 90 randomized (85 completers) mildly hypercholesterolemic adults, an 8-week nutraceutical tablet containing phytosterols plus red yeast rice markedly lowered LDL-C and other lipids versus placebo.

Trust comment: Well-conducted double-blind RCT with 85 completers and significant lipid changes, but the product combined phytosterols with red yeast rice so effects are not attributable to phytosterols alone.

Study Details

PMID:33066334
Participants:85
Impact:mean change −32.5 ±30.2 mg/dL in active group (−19.8%); between-group difference −39.2 mg/dL (95% CI −48.6 to −29.8), P<0.0001
Trust score:4/5

In 127 hypercholesterolemic adults, probiotic L. reuteri reduced LDL-C and lowered circulating plant sterol markers (campesterol, sitosterol, stigmasterol), consistent with reduced sterol absorption.

Trust comment: Large randomized, placebo-controlled trial with clear biochemical effects on sterol markers and LDL-C, but intervention was a probiotic (indirect effect on phytosterol handling), not phytosterol supplementation.

Study Details

PMID:22990854
Participants:127
Impact:−11.64% versus placebo (P<0.001)
Trust score:3/5

Daily bread with 2.3 g phytosterols for 4 weeks lowered total and LDL cholesterol and reduced calculated CVD risk; HDL and TG unchanged.

Trust comment: Double-blind, placebo-controlled RCT with moderate sample and clear lipid endpoints.

Study Details

PMID:30990213
Participants:75
Impact:−10.6% (−0.49 mmol/L)
Trust score:4/5

A 3-month nutraceutical (contains 1.5 g phytosterols plus other agents) reduced total cholesterol, LDL-C and ApoB and lowered hs-CRP vs placebo.

Trust comment: Randomized, double-blind, placebo-controlled trial but intervention is a combination product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:31035469
Participants:40
Impact:−19.7% at 3 months
Trust score:4/5

Incorporating phytosterols (2 g/d) in a cocoa cream for 4 weeks reduced LDL-C and improved inflammatory/oxidative biomarkers (hsCRP, oxLDL) compared with control.

Trust comment: Well-controlled, double-blind multi-arm RCT with adequate sample; phytosterols were one component of tested formulations.

Study Details

PMID:22383996
Participants:113
Impact:product with phytosterols: −11.2% (−0.47 mmol/L); LMN (sterols+fiber): −9.2% (−0.39 mmol/L)
Trust score:4/5

Daily spread with ~2.2 g plant sterols for 6 weeks lowered fasting triglycerides and LDL-C in individuals with or at risk of T2DM (per-protocol analysis).

Trust comment: Large, randomized, double-blind, placebo-controlled study with predefined endpoints and appropriate analyses (per-protocol reported).

Study Details

PMID:29795368
Participants:138
Impact:−4.6% (−0.18 mmol/L)
Trust score:5/5

Softgel providing 1.8 g/day esterified plant sterols/stanols reduced LDL-C, non-HDL-C and total cholesterol versus placebo in adults with primary hypercholesterolemia.

Trust comment: Randomized, double-blind crossover replication study but small sample (n=30) limits precision.

Study Details

PMID:24287284
Participants:30
Impact:−4.3% (placebo-adjusted)
Trust score:4/5

Placebo-controlled double-blind trial: rapidly disintegrating stanol-lecithin tablets (1.26 g stanols/day) for 6 weeks lowered LDL compared with placebo; slowly disintegrating capsules had no effect.

Trust comment: Randomized double-blind placebo-controlled trial with 52 subjects and significant LDL reductions for rapidly disintegrating tablet formulation.

Study Details

PMID:15969949
Participants:52
Impact:-10.4% (tablets vs placebo, 6 weeks)
Trust score:4/5

Pragmatic RCT of written dietary advice that included plant sterol recommendations among many items; overall no between-group LDL benefit, but short-term association found between self-reported use of plant sterol advice and lower LDL at 3 weeks.

Trust comment: Good-sized pragmatic RCT, but phytosterols were one of multiple self-selected dietary advices (observational association within trial), limiting causal inference.

Study Details

PMID:35267997
Participants:113
Impact:Association: −0.027 mmol/L at 3 weeks per reported plant-sterol advice adherence (β = −0.027, p = 0.009)
Trust score:3/5

Randomized double-blind crossover trial: 1.8 g/day non-esterified plant sterol/stanol tablets (6 weeks) added to TLC diet produced modest but significant reductions in atherogenic lipids.

Trust comment: Well-conducted randomized crossover trial with objective lipid endpoints, though sample size was modest.

Study Details

PMID:22087585
Participants:32
Impact:-4.9% (active vs control difference)
Trust score:4/5

In healthy Japanese volunteers, daily plant stanol ester spread modestly lowered total and LDL cholesterol and markedly reduced oxidized LDL over the trial period.

Trust comment: Randomized, placebo-controlled trial with 105 participants; short duration but well-controlled and directly tests plant stanol-containing product.

Study Details

PMID:12679174
Participants:105
Impact:-9.6% (2 g/d) and -7.3% (3 g/d)
Trust score:4/5

In hypercholesterolemic adults, plant sterol intake (with or without exercise) lowered LDL cholesterol and increased adiponectin; no changes were seen in apoA1, apoB, ghrelin, or growth hormone.

Trust comment: Randomized 8-week parallel-arm trial (n=84) directly testing plant sterols; moderate size and randomized but relatively short duration.

Study Details

PMID:18066136
Participants:84
Impact:-0.49 mmol/L (plant sterol group)
Trust score:4/5

Crossover RCT: yogurt with 4 g/day plant stanol esters reduced total and LDL cholesterol over 4 weeks versus placebo without safety concerns.

Trust comment: Randomized double-blind placebo-controlled crossover with good compliance and clear lipid endpoints, though short duration (4 weeks per period).

Study Details

PMID:25099071
Participants:40
Impact:-10.3% (measured) and -12.2% (calculated) vs placebo (p<0.001)
Trust score:4/5

Replacing usual cooking oil with plant sterol–enriched palm oil for 8 weeks lowered total and LDL cholesterol in hyperlipidemic adults; CRP showed a small rise vs baseline but no significant between-group change.

Trust comment: Double-blind randomized controlled trial (100 completers) with clear lipid outcomes; moderate sample and short duration limit long-term inference.

Study Details

PMID:39408337
Participants:100
Impact:-7.71% (vs control)
Trust score:4/5

Plant sterol ester–enriched low-fat milk and yoghurt reduced total and LDL cholesterol (~5–10%) in modestly hypercholesterolemic adults, with no effect on HDL or triglycerides.

Trust comment: Randomized crossover trials (total completers n≈79) showing consistent cholesterol reductions in modestly hypercholesterolemic subjects; small sample sizes per study phase.

Study Details

PMID:15316827
Participants:79
Impact:-5% to -10% (≈0.23–0.27 mmol/L; study-specific values)
Trust score:4/5

In type 2 diabetic patients, a phytosterol-enriched spread reduced total and LDL cholesterol (peak ~5–7% at 4 weeks) with effects attenuating over 12 weeks; small HDL increase and transient HbA1c reduction observed.

Trust comment: Randomized, double-blind controlled trial in 85 T2D patients with repeated measures showing modest lipid improvements but attenuation over time.

Study Details

PMID:12638032
Participants:85
Impact:-6.8% (at 4 weeks vs baseline; effect attenuated thereafter)
Trust score:4/5

Adults with mild–moderate hypercholesterolemia who ate low-fat foods providing 1.8 g/day phytosterols plus oat beta-glucan for 6 weeks had small but significant reductions in LDL and total cholesterol.

Trust comment: Randomized, double-blind, controlled trial with 112 participants showing modest LDL and total cholesterol lowering with phytosterol-containing foods.

Study Details

PMID:12612157
Participants:112
Impact:-3.7% vs +0.4% in control (P = 0.013)
Trust score:4/5

Adults with low baseline lathosterol-to-cholesterol ratio (low endogenous synthesis) had larger reductions in total and LDL cholesterol when consuming 2 g/day plant sterols for 28 days, whereas high-synthesis individuals did not respond.

Trust comment: Randomized, single-blind crossover trial with biomarker-based stratification showing that baseline synthesis marker predicts response to plant sterols.

Study Details

PMID:25733626
Participants:63
Impact:-0.17 ± 0.04 mmol/L overall; -0.29 ± 0.05 mmol/L in low-synthesis subgroup (P = 0.0002)
Trust score:4/5

In healthy and mildly hypercholesterolemic adults, margarines enriched with plant sterols or sitostanol esters reduced total and LDL cholesterol by about 8–13% over ~3.5-week treatment periods without lowering HDL.

Trust comment: Randomized, double-blind Latin-square design with 95 completers demonstrating consistent LDL/TC lowering by sterol-enriched margarines.

Study Details

PMID:9630383
Participants:95
Impact:-8–13% (0.37–0.44 mmol/L) vs control
Trust score:4/5

Six months of plant stanol ester (~3 g/day) reduced LDL (~10%) and non-HDL cholesterol and improved arterial stiffness in small arteries (AI) and prevented progression of large-artery stiffness (CAVI) in men.

Trust comment: Well-conducted randomized, double-blind parallel trial with vascular and lipid endpoints in 92 completers showing LDL lowering and improvements in surrogate vascular measures.

Study Details

PMID:23841572
Participants:92
Impact:-10.2% vs control (p<0.001)
Trust score:4/5

Randomized double-blind trial (4 weeks) showed a spread with 2.0 g/day plant sterols + 1.0 g/day EPA+DHA lowered triglycerides and LDL‑cholesterol versus placebo.

Trust comment: Large randomized double-blind placebo-controlled trial with high compliance and objective lipid outcomes; additive fish‑oil component means some effects may be due to combined treatment.

Study Details

PMID:29725824
Participants:259
Impact:−5.2% versus placebo (p<0.001)
Trust score:5/5

Over 85 weeks in 30 statin users, plant sterol margarine raised serum campesterol and lowered LDL-C; increased campesterol correlated with a small, non-significant increase in retinal venular diameter.

Trust comment: Randomized long-term trial but very small groups (N=11,8,11) limiting precision and generalizability.

Study Details

PMID:21122856
Participants:30
Impact:sterol group -0.33 mmol/L; stanol group -0.38 mmol/L (both significant vs control)
Trust score:3/5

In 157 adults with hypercholesterolemia consuming milk with 1.58 g/day phytosterol ester for 2 months, total cholesterol and LDL-C were significantly reduced vs normal milk and non-dairy groups.

Trust comment: Community RCT with moderate size and 2-month follow-up; results support LDL/TC lowering but some outcomes lacked detailed magnitudes in report.

Study Details

PMID:29903120
Participants:157
Impact:significant decrease vs control after 2 months (exact values not provided)
Trust score:3/5

In people with hyperlipidemia, a diet portfolio including plant sterols lowered LDL cholesterol substantially over 6 months compared with a low-saturated-fat control.

Trust comment: Large, multicenter randomized trial with modified ITT and clear significant LDL-C reductions attributable to the dietary portfolio containing plant sterols.

Study Details

PMID:21862744
Participants:345
Impact:-13.8% (intensive portfolio; -26 mg/dL), -13.1% (routine portfolio; -24 mg/dL) vs -3.0% (-8 mg/dL) control over 6 months
Trust score:5/5

In a controlled, crossover feeding study, adding plant sterols (3.3 g/day) reduced total and LDL cholesterol independently and additively with dietary fat reduction.

Trust comment: Double-blind, randomized, controlled crossover feeding study with precise interventions but small sample (n=22) limiting generalizability.

Study Details

PMID:19145455
Participants:22
Impact:-12.4% with plant sterols
Trust score:4/5

In hyperlipidemic subjects, a dietary portfolio high in plant sterols and other components reduced LDL-C nearly as much as 20 mg lovastatin over 4 weeks.

Trust comment: Randomized crossover within-subject comparison (n=34) gives strong within-person evidence though short (1 month) treatment periods and small sample limit long-term inference.

Study Details

PMID:15699225
Participants:34
Impact:Portfolio: -29.6% (4 wk); Statin (lovastatin): -33.3% (4 wk); Control diet: -8.5% (4 wk)
Trust score:4/5

Controlled feeding trials showed that low- and moderate-fat plant sterol–fortified soymilks reduced total and LDL cholesterol (≈10–15%) versus 1% dairy milk; moderate-fat soymilk also reduced cholesterol absorption and triglycerides.

Trust comment: Well-controlled randomized crossover feeding trials with measured cholesterol kinetics and significant lipid effects, though two separate study groups (n=33 and n=23) and short duration.

Study Details

PMID:19843338
Participants:33
Impact:Low-fat soymilk: -13%; Moderate-fat soymilk: -15% vs 1% milk (29 days)
Trust score:4/5

In people with metabolic syndrome and high LDL, adding a soy/phytosterol medical food plus other plant compounds to a diet improved several cholesterol measures more than diet alone.

Trust comment: Randomized trial but small subgroup (n=24) and the intervention combined multiple compounds, limiting attribution specifically to phytosterols.

Study Details

PMID:21122628
Participants:24
Impact:decreased vs control (greater improvement in PED arm, P < 0.05)
Trust score:3/5

In statin-intolerant/unwilling adults, snack products containing a mix of cholesterol-lowering bioactives (including phytosterols) twice daily reduced LDL and total cholesterol over four weeks compared with control snacks.

Trust comment: Well-designed double-blind randomized crossover trial with clear numeric effects, though the product contained multiple active ingredients including phytosterols.

Study Details

PMID:35079806
Participants:54
Impact:-8.80 ± 1.69% vs control (P < 0.0001)
Trust score:5/5

In statin-treated patients, adding plant sterol or stanol (2.5 g/day) for 16 weeks lowered LDL cholesterol but did not change antioxidant status, oxidative stress markers, endothelial or low-grade inflammation markers.

Trust comment: Double-blind randomized placebo-controlled design in statin-treated patients with clear LDL effect but modest sample size.

Study Details

PMID:17487211
Participants:41
Impact:-0.34 mmol/L (95% CI -0.67 to -0.04 mmol/L), P = 0.026
Trust score:4/5

In postmenopausal women, different stanol-enriched margarines and butters (≈2.4–3.2 g/d stanols) reduced LDL cholesterol and LDL/HDL ratio and modestly increased HDL, while some carotenoids decreased.

Trust comment: Controlled double-blind crossover study with direct measured lipid effects but small sample of 23 postmenopausal women limits generalizability.

Study Details

PMID:10337856
Participants:23
Impact:-8% and -10% with two margarine formulations vs baseline; -12% with sitostanol-rich butter vs butter period (P < 0.05)
Trust score:4/5

In healthy middle-aged adults, daily plant stanol ester margarine reduced total cholesterol, LDL and triglycerides over 4 weeks of supplementation.

Trust comment: Randomized, double-blind but small sample and short duration limit generalizability.

Study Details

PMID:16546486
Participants:26
Impact:-13% (after 4 weeks MS)
Trust score:3/5

A spread containing milk peptides plus 2 g plant sterols daily modestly reduced home systolic blood pressure and lowered total and LDL cholesterol versus placebo.

Trust comment: Randomized double-blind design and moderate size, but effect attribution to plant sterols is confounded by co-administered bioactive peptides.

Study Details

PMID:22398753
Participants:104
Impact:-0.16 mmol/L (active vs +0.18 mmol/L placebo, p=0.006)
Trust score:3/5

In healthy volunteers consuming margarine with ~8.6 g/day phytosterols, total and LDL cholesterol fell substantially with no biologically important adverse effects on gut flora or female sex hormones.

Trust comment: Randomized, placebo-controlled dietary study under controlled conditions but small sample size; primary cholesterol effects robust.

Study Details

PMID:10654588
Participants:24
Impact:-23% (P<0.001)
Trust score:4/5

Daily intake of 1.6 g plant sterol esters in a spread for 1 year lowered total and LDL cholesterol modestly and was safe with no adverse hormone or clinical-chemical effects.

Trust comment: Large (n=185), randomized double-blind placebo-controlled 1-year trial with comprehensive safety measures.

Study Details

PMID:12771969
Participants:185
Impact:−6% (average over 1 year)
Trust score:5/5

Daily intake of ~2 g phytosterols delivered in milk for 4 weeks lowered LDL cholesterol by about 7–8% in hypercholesterolaemic subjects.

Trust comment: Randomized placebo-controlled crossover in hypercholesterolemic subjects (n=43) with direct lipid and sterol biomarker measures.

Study Details

PMID:22018049
Participants:43
Impact:−8.0% (PS-SM) and −7.4% (PS-VFM) vs control
Trust score:4/5

In a controlled crossover trial in overweight hyperlipidemic men, phytosterols delivered in a functional oil reduced total and LDL cholesterol compared with olive oil.

Trust comment: Well-controlled crossover dietary trial but small sample (n=23) limiting generalizability.

Study Details

PMID:16483884
Participants:23
Impact:endpoint 3.12 vs 3.54 mmol/L (functional oil vs olive oil); significant (P=.0221)
Trust score:3/5

In medicated secondary prevention patients, a low-fat diet that included 2 g/day phytosterols (TLCD) decreased LDL and oxidized LDL compared with a Mediterranean diet, but diets differed in multiple components.

Trust comment: Randomized dietary comparison in medicated patients (n=40) but phytosterols were part of a broader dietary intervention, limiting attribution to phytosterols alone.

Study Details

PMID:21890081
Participants:40
Impact:decreased with TLCD (contains 2 g/day phytosterols) versus Mediterranean diet (no numeric value reported)
Trust score:3/5

Hypercholesterolemic men consuming 21 g/day of a plant sterol-enriched spread had modest reductions in total and LDL cholesterol; beta-carotene fell unless dietary fruit/veg advice was followed.

Trust comment: Randomized double-blind crossover study with 48 participants and relevant biochemical endpoints, though short intervention periods.

Study Details

PMID:15546434
Participants:48
Impact:-7.1%
Trust score:4/5

People eating bakery products delivering 3.2 g/day sterol esters for 8 weeks had lower total and LDL cholesterol without reductions in measured antioxidants.

Trust comment: Randomized double-blind placebo-controlled trial with direct sterol-enriched food intervention and clear biochemical outcomes, moderate sample size.

Study Details

PMID:14519792
Participants:57
Impact:-0.26 mmol/L (within-group) ; between-group difference 0.36 mmol/L (14.7%)
Trust score:4/5

Phytostanol-ester enriched foods reduced LDL-C ~10–13% and lowered cholesterol absorption similarly in high and low absorbers.

Trust comment: Post-hoc analysis of randomized, double-blind controlled trials in humans with direct biochemical measures; modest sample but appropriate design.

Study Details

PMID:38301283
Participants:41
Impact:reduction 10–13% (vs control)
Trust score:4/5

A once-daily 2.5 g phytosterol drink reduced LDL-C, total cholesterol and ApoB-100 versus placebo; larger reductions seen in those with higher Mediterranean-diet adherence.

Trust comment: Double-blind, randomized, placebo-controlled crossover in humans with good completion and compliance, though short treatment periods (3 weeks) limit long-term conclusions.

Study Details

PMID:37960208
Participants:49
Impact:decrease (statistically significant); −9.2% ±11.8% in high Mediterranean-diet adherers
Trust score:4/5

In 84 sedentary adults with high cholesterol, 8 weeks of plant sterol supplementation lowered total cholesterol and absolute LDL and increased blood plant-sterol markers; combining sterols with exercise gave the best lipid changes.

Trust comment: Randomized, placebo-controlled 8‑week trial in humans with clear lipid outcomes, moderate sample size.

Study Details

PMID:15531661
Participants:84
Impact:decreased (absolute reduction; % change not significant vs baseline-to-endpoint)
Trust score:4/5

In 41 statin-treated coronary patients, 6 weeks of plant-sterol spread (2 g/day) reduced LDL (~16.6%); combining plant sterols with ezetimibe gave the largest LDL drop (~27.3%).

Trust comment: Randomized but open‑label, small and short-duration trial in patients on statins; results plausible but limited by design and size.

Study Details

PMID:28098515
Participants:41
Impact:PS alone -16.6%; EZ+PS -27.3% (6 weeks)
Trust score:3/5

In ~84 mildly hypercholesterolemic patients, 2 g/day phytosterol-enriched low‑fat milk for 3 months reduced total and LDL cholesterol similarly across diets (LDL reductions ~7–9.6%) without consistent harm to carotenoids when combined with a healthy diet.

Trust comment: Randomized 3‑month parallel trial with clear lipid endpoints and moderate sample size; diet stratification well described.

Study Details

PMID:20456813
Participants:84
Impact:-7.0% to -9.6% (depending on diet group) after 3 months
Trust score:4/5

In 67 hypercholesterolemic adults, consuming cocoa snack bars with 1.5 g phytosterols twice daily for 6 weeks lowered total cholesterol (~4.7%) and LDL (~6%) and the total/HDL ratio, with a small reduction in lipid-adjusted beta‑carotene.

Trust comment: Randomized, double‑blind parallel trial with moderate sample size and clear lipid outcomes; short duration (6 weeks).

Study Details

PMID:17081832
Participants:67
Impact:-6.0% (6 weeks)
Trust score:4/5

Healthy adults consuming plant sterol or stanol margarine had lower LDL cholesterol; sterols did not raise oxyphytosterols, while stanols reduced some oxyphytosterol metabolites.

Trust comment: Randomized double-blind cross-over trial in 43 healthy adults with appropriate analytical methods; moderate sample size.

Study Details

PMID:23375753
Participants:43
Impact:sterols -8.1%; stanols -7.8%
Trust score:4/5

In high cardiovascular risk subjects, increasing phytosterols from natural foods (nuts) raised phytosterol intake and was associated with lower LDL cholesterol and improved LDL/HDL ratio.

Trust comment: Substudy within a larger randomized dietary trial (PREDIMED) with 106 participants; reasonable design though observational components limit causality.

Study Details

PMID:19412676
Participants:106
Impact:-0.27 mmol/L (~-8.3%) vs low-fat
Trust score:4/5

In metabolic syndrome subjects, fermented milk containing lactotripeptides plus 2 g/d plant sterol esters produced a borderline lipid-lowering effect but did not change blood pressure or haemodynamic measures versus placebo.

Trust comment: Randomized double-blind trial (n=104) but combined active ingredients (lactotripeptides + plant sterols) and borderline significance limit attribution specifically to phytosterols.

Study Details

PMID:26168857
Participants:104
Impact:small decrease (≈ -0.1 to -0.3 mmol/L; borderline significance)
Trust score:3/5

Stanol ester intervention lowered cholesterol but did not affect serum 25‑hydroxyvitamin D; the study did not investigate vitamin D supplementation effects.

Trust comment: Large randomized controlled trial (n=318) with clear dose-response and clinical lipid endpoints; good reliability for cholesterol effects.

Study Details

PMID:10593347
Participants:318
Impact:-10.1% (US 3 g/d group)
Trust score:4/5

In hypercholesterolemic adults, a 12-week plant-sterol-enriched spread lowered total and LDL cholesterol and raised plasma phytosterols but did not change endothelial function (FMD).

Trust comment: Large randomized, double-blind, placebo-controlled trial with rigorous vascular measures and biochemical endpoints (well-powered and well-conducted).

Study Details

PMID:25809853
Participants:199
Impact:-6.7% (≈ -0.26 mmol/L vs control)
Trust score:5/5

Yoghurt enriched with 1–2 g/d plant sterols lowered total and LDL cholesterol in a dose-dependent manner over the study periods; HDL and triglycerides were unchanged.

Trust comment: Randomized crossover design and significant lipid effects reported, but small sample and some outcomes not numerically detailed in abstract.

Study Details

PMID:11502237
Participants:30
Impact:decrease (dose-dependent; P<0.001)
Trust score:4/5

In hypercholesterolemic subjects, ultra-heat-treated soy protein preparations did not lower cholesterol; LDL cholesterol unexpectedly increased by ~17–19% across groups.

Trust comment: Randomized double-blind placebo-controlled study with clear unexpected findings, though mechanistic details limited in abstract.

Study Details

PMID:17162329
Participants:80
Impact:increase of ~17–19% (no LDL-lowering effect observed)
Trust score:4/5

Adults with moderate high cholesterol drank phytosterol-enriched soy milk and had lower LDL and endothelin-1, with some lipid improvements in higher‑LDL participants.

Trust comment: Randomized, double‑blind, placebo‑controlled human trial but small sample (n=38) and short treatment periods limit generalizability.

Study Details

PMID:32455866
Participants:38
Impact:decrease (significant)
Trust score:4/5

Low-dose soy protein with added beta-sitosterol given daily for 40 days lowered LDL-C and apoB but did not affect Lp(a) or oxidized LDL antibodies.

Trust comment: Small single-arm pre-post study (36 subjects) with statistically significant LDL-C and apoB changes but limited by sample size and design.

Study Details

PMID:15309453
Participants:36
Impact:-19.64 mg/dL (mean change), p < 0.001
Trust score:3/5

Sitostanol-ester margarine (3 g/d) reduced total and LDL cholesterol in postmenopausal women, including when combined with statin therapy.

Trust comment: Randomized, double-blind crossover trial in clinical population with clear biochemical outcomes, but modest sample size.

Study Details

PMID:9416886
Participants:32
Impact:-20% (sitostanol margarine vs baseline), P < .01; -16% (±5%) when combined with simvastatin, P < .01
Trust score:4/5

A Mediterranean low-glycemic diet improved metabolic syndrome variables; adding a phytochemical-rich medical food containing phytosterols led to greater improvements in LDL and related lipoprotein markers and lowered homocysteine.

Trust comment: Randomized 2-arm trial with adequate sample size and clinically relevant endpoints, though phytosterols were part of a multi-ingredient medical food.

Study Details

PMID:21600524
Participants:89
Impact:Greater reduction in intervention arm (medical food with phytosterols) vs control over 12 weeks (P < .05)
Trust score:4/5

Daily intake of 2 g plant sterols reduced LDL-C and triglycerides in mildly hypercholesterolaemic adults; fish oil mainly reduced TAG and increased HDL; combination lowered TAG without interaction on cholesterol.

Trust comment: Large (n=200), double-blind randomized 2x2 factorial trial with clear effects on lipids but short duration (4 weeks).

Study Details

PMID:19296875
Participants:200
Impact:-4.5% (plant sterols main effect)
Trust score:4/5

A novel phytosterol ester emulsion (1.5 g/day) given as capsules reduced LDL-C by ~10% over one month compared with placebo in a remote crossover trial.

Trust comment: Randomized double-blind crossover design with objective lab measures but small sample and compliance limitations in a remote study.

Study Details

PMID:31491873
Participants:32
Impact:-16.2 mg/dL difference supplement vs placebo (−10.2%), p = 0.008
Trust score:4/5

Cookies containing psyllium plus 2.6 g/day plant sterols for 4 weeks reduced total and LDL cholesterol and decreased apoB and numbers of atherogenic lipoprotein subfractions.

Trust comment: Randomized, double-blind crossover placebo-controlled study with clear lipid changes but modest sample size and short duration.

Study Details

PMID:16988115
Participants:33
Impact:From 3.48 to 3.14 mmol/L (−0.34 mmol/L), P < 0.01
Trust score:4/5

Daily low-fat milk with free plant sterols for 4 weeks reduced LDL cholesterol in mildly hypercholesterolemic adults.

Trust comment: Randomized, double-blind, placebo-controlled crossover with 71 completers; well-conducted but moderate sample size.

Study Details

PMID:15164106
Participants:71
Impact:-7.1% (1.2 g/day) and -9.6% (1.6 g/day) vs placebo
Trust score:4/5

Short crossover feeding study showed serum campesterol and sitosterol rose proportionally to intake and both sterol/stanol mixtures similarly lowered LDL cholesterol.

Trust comment: Randomized crossover dietary intervention in 44 healthy adults with clear biochemical outcomes; moderate sample size appropriate for metabolic endpoints.

Study Details

PMID:12949359
Participants:44
Impact:lowered similarly by both sterol/stanol mixtures (no large dependence on ratio)
Trust score:4/5

Daily phytosterol‑enriched margarine modestly lowered total and LDL cholesterol and raised HDL over 3 weeks, with larger LDL effects in higher‑intake subgroups.

Trust comment: Randomized, double-blind, placebo-controlled crossover with clear lipid outcomes and N=63 supports moderate confidence.

Study Details

PMID:11833047
Participants:63
Impact:-5.4% (144 vs 154 mg/dL)
Trust score:4/5

Daily rice‑bran plant sterols (2.1 g) lowered total and LDL cholesterol in healthy adults; triterpene alcohols showed no effect.

Trust comment: Crossover, double-blind study with N=60 and quantified lipid changes gives credible evidence for cholesterol lowering by plant sterols.

Study Details

PMID:11101479
Participants:60
Impact:-0.20 mmol/L (~-9%)
Trust score:4/5

~2 g/day plant stanol or sterol esters for 10 weeks lowered LDL cholesterol modestly but did not change flow-mediated dilation; sterol esters slightly reduced brachial artery diameter.

Trust comment: Randomized double-blind crossover with parallel controls and adequate sample size; direct phytosterol intervention supports moderate-high trust.

Study Details

PMID:16386259
Participants:76
Impact:reduced by ~6–9% from baseline (STAEST/STEEST) and by ~9–12% vs controls (p<0.05)
Trust score:4/5

Short trials testing doses of plant sterol in dressings found LDL lowering at higher doses and no safety problems at very high dose.

Trust comment: Randomized human trial with modest sample size and short duration; subgroup effects reported which reduce robustness.

Study Details

PMID:18075220
Participants:89
Impact:Significant reduction vs control at 1200 mg/day in subgroup with TC ≥220 mg/dL; near-significant at 800 mg/day (p=0.053); no change at 400 mg/day
Trust score:3/5

Daily phytosterol-enriched milk (1.57 g/day) for 28 days reduced LDL-C and increased LDL resistance to oxidation and altered LDL lipid composition.

Trust comment: Randomized crossover with detailed lipidomics but small sample and short interventions limit generalizability.

Study Details

PMID:25773888
Participants:32
Impact:Greater reduction from baseline with phytosterol-milk compared with baseline and compared to ω3-milk (magnitude not specified)
Trust score:3/5

Crossover trial: fish-oil–ester plant sterols lowered triglycerides markedly and plant sterol esters lowered LDL and apoB compared with control oil.

Trust comment: Small, semi-randomized single-blind crossover with multiple interventions; physiological endpoints measured but limited sample size.

Study Details

PMID:17158440
Participants:21
Impact:Significantly lower after fish-oil–PS and sunflower-PS vs control olive oil
Trust score:3/5

Three-month randomized study: plant stanol esters (2 g/day) lowered LDL-C but produced no overall change in arterial elasticity or endothelial function; subjects with low baseline values improved.

Trust comment: Large randomized trial with objective vascular and lipid endpoints; subgroup effects reported and overall vascular effects were null.

Study Details

PMID:18279553
Participants:200
Impact:Reduced by ~9% compared with controls (P < 0.001)
Trust score:4/5

Older hyperlipidemic adults consuming soy milk powder with phytosterol esters (≈2 g/day free phytosterols) for 6 months had reduced total and LDL cholesterol versus placebo.

Trust comment: Large randomized placebo-controlled trial (n=170) with clinically relevant lipid endpoints and 6-month follow-up.

Study Details

PMID:27440543
Participants:170
Impact:-11.4% (6 months vs control)
Trust score:4/5

In a 3-period crossover in healthy adults, 2 g/day plant sterols reduced cholesterol absorption but did not significantly lower LDL due to a compensatory increase in synthesis.

Trust comment: Randomized, double-blind crossover with isotope measures of absorption/synthesis (n=49); mechanistic and well-controlled.

Study Details

PMID:28112077
Participants:49
Impact:no significant reduction
Trust score:4/5

Daily intake of 2 g plant stanols in a yogurt drink for 12 months produced modest but significant LDL cholesterol reductions (~11%) in adults with hypercholesterolemia.

Trust comment: Large randomized, double-blind placebo-controlled trial (n=182) with 12-month duration and clinically meaningful lipid endpoints.

Study Details

PMID:25541227
Participants:182
Impact:-13.7 mg/dL (mean difference) / -11.0% (mean % change)
Trust score:4/5

An 8.8 g/day plant stanol ester intervention for 10 weeks lowered total and LDL cholesterol and decreased absorption markers while increasing synthesis markers; serum stanol levels rose modestly and normalized after washout.

Trust comment: Randomized double-blind parallel study (n=49) with clear biochemical endpoints; moderate sample size and 10-week duration.

Study Details

PMID:19774436
Participants:49
Impact:-17% (vs control)
Trust score:4/5

A 12-week low-GI diet including 30 g soy protein and 4 g phytosterols/day lowered cholesterol and triglycerides more than a standard diet in postmenopausal women.

Trust comment: Randomized 12-week trial with matched caloric/exercise controls and clear between-group lipid reductions, moderate sample size.

Study Details

PMID:16459222
Participants:53
Impact:-14.8%
Trust score:4/5

Six-month randomized double-blind trial where 3 g/day plant stanol esters reduced LDL-C ~10% without changing serum PCSK9.

Trust comment: Well-powered randomized double-blind 6-month trial with clear lipid endpoint and appropriate assays.

Study Details

PMID:25857271
Participants:92
Impact:-10%
Trust score:5/5

Crossover trial showing margarines with 2 g/day plant sterols (rapeseed or tall oil) reduced LDL-C and apoB but lowered lipid-adjusted beta-carotene.

Trust comment: Double-blind randomized crossover with objective lipid measurements, moderate sample size; some nutrient effects noted.

Study Details

PMID:19748247
Participants:59
Impact:-8.2% to -9.0% (sterol margarines)
Trust score:4/5

Six-week addition of 1.8 g soy stanol tablets to ongoing statin therapy produced additional ~9% LDL-C lowering versus placebo.

Trust comment: Double-blind placebo-controlled trial but small sample size limits generalizability.

Study Details

PMID:16442399
Participants:26
Impact:-9.1% (-12.2 mg/dl)
Trust score:3/5

Forty-two-day randomized double-blind trial where 1.6 g/day phytosterol yogurt reduced LDL-C ~10–12%, lowered triglycerides, and increased the proportion reaching LDL targets.

Trust comment: Multicentre randomized double-blind placebo-controlled trial with clinically relevant endpoints and good sample size.

Study Details

PMID:18193377
Participants:83
Impact:-10.6% to -12.2%
Trust score:5/5

In hypercholesterolemic adults, a low-fat spread with plant sterols reduced LDL cholesterol and triglycerides; adding EPA+DHA further reduced VLDL components.

Trust comment: Large randomized double-blind parallel trial; short treatment (4 weeks) and combined interventions limit attribution solely to plant sterols.

Study Details

PMID:26019023
Participants:282
Impact:reduced (PS treatment)
Trust score:4/5

Daily soy drink with plant sterols for 8 weeks lowered LDL, total and non-HDL cholesterol in adults with moderate hypercholesterolemia.

Trust comment: Randomized double-blind placebo-controlled trial with clear LDL primary outcome but small sample and short duration (8 weeks).

Study Details

PMID:18837970
Participants:49
Impact:-6.76% at 8 weeks (P<0.01)
Trust score:4/5

In hypercholesterolemic children, sterol-ester spreads lowered plasma total and LDL cholesterol and increased red-cell plant sterol ratios when sterol esters were consumed.

Trust comment: Randomized double-blind crossover in children with small sample (n=23); design strong but limited power and pediatric-specific population.

Study Details

PMID:12756385
Participants:23
Impact:-9% with sterol ester (vs baseline/comparator)
Trust score:3/5

In overweight adults on an 8-week calorie-restricted diet, adding plant sterols to rice bran led to larger reductions in total (and a trend for LDL) cholesterol versus rice bran alone.

Trust comment: Small randomized study (n=24) with short duration and weight-loss regimen that may confound lipid changes, but randomized design supports moderate confidence.

Study Details

PMID:24955613
Participants:24
Impact:additional decrease ~22.3 ± 25.2 mg/dL (RB+PS vs RB), p=0.062 (trend)
Trust score:3/5

In a randomized double-blind crossover (4-week PS phase), soy milk with phytosterols (1.6 g/day) modestly lowered total cholesterol (~-5.5%) and LDL-C (~-7.6%) and raised plasma campesterol and sitosterol, with changes in synthesis/absorption markers.

Trust comment: Well-controlled randomized crossover with objective biochemical endpoints (n=38) supports moderate-high confidence for short-term lipid effects.

Study Details

PMID:35397367
Participants:38
Impact:decrease ~7.6% (183 → 169 mg/dL, p=0.001)
Trust score:4/5

Phytosterol-enriched chocolate (1.8 g/d) given for 4 weeks lowered total and LDL cholesterol without affecting HDL or triglycerides and raised markers of sterol absorption; no adverse effects.

Trust comment: Randomized double-blind placebo-controlled RCT in 70 hypercholesterolemic subjects with clear numeric lipid changes over 4 weeks.

Study Details

PMID:12425728
Participants:70
Impact:-10.3% (-0.49 mmol/L)
Trust score:4/5

Replacing butter with a polyunsaturated spread containing 2 g plant sterols daily in a reduced-fat diet reduced total and LDL cholesterol more than spread without sterols.

Trust comment: Randomized double-blind crossover dietary intervention in 50 participants with clear LDL/total cholesterol reductions.

Study Details

PMID:12548313
Participants:50
Impact:-12.3% (from 3.98 to 3.49 mmol/L)
Trust score:4/5

Both stanol-ester and sterol-ester margarines (~2 g/d) consumed for 4 weeks reduced total and LDL cholesterol similarly; sterol esters increased serum sitosterol and campesterol.

Trust comment: Randomized, double-blind Latin-square repeated measures design with 34 completers showing consistent cholesterol reductions.

Study Details

PMID:11002384
Participants:34
Impact:STAEST -12.7%; STEEST -10.4%
Trust score:4/5

Daily dressing containing 800 mg plant sterol for 12 weeks reduced total cholesterol, LDL-C and ApoB versus placebo with no adverse events reported.

Trust comment: Placebo-controlled double-blind trial in 59 subjects showing significant lipid reductions though numeric magnitudes not reported in abstract.

Study Details

PMID:18075221
Participants:59
Impact:decreased (significant at 4, 8 and 12 weeks)
Trust score:4/5

6-week crossover in hypercholesterolemic adults: sterol-enriched yogurt and vine-ripened tomato sauce (high adherence) both reduced LDL-C; tomato sauce effects similar magnitude to sterol product in adherent subjects.

Trust comment: Crossover trial with 91 completers and dietetic supervision; partially unblinded due to different products but reasonable methodology.

Study Details

PMID:33407609
Participants:91
Impact:Sterol-yogurt −16 ±21 mg/dL; Tomato sauce (high adherence) −12 ±17 mg/dL (adjusted reductions −15.3±2 and −12.4±2 mg/dL respectively)
Trust score:4/5

Adding 2.7 g phytosterols to daily ground beef for 4 weeks lowered total and LDL cholesterol in young men with mild hypercholesterolemia.

Trust comment: Triple-blind randomized trial with clear lipid reductions but modest sample size (n=34).

Study Details

PMID:12081816
Participants:34
Impact:−14.6% from baseline (P<0.001)
Trust score:4/5

Obese Japanese men with high LDL took rice bran ASG extract or placebo for 12 weeks; the extract group had greater reductions in LDL and some fat measures.

Trust comment: Checklist: confirm phytosterol exposure; extract top outcomes; verify participant count; evaluate quality; report changes — randomized double-blind trial with 51 participants, moderate sample and clear positive effects on LDL and non-HDL cholesterol.

Study Details

PMID:25817289
Participants:51
Impact:decrease (significant vs placebo)
Trust score:4/5

Adults with mild-moderate hypercholesterolemia consumed low-fat yoghurt with ~1.9 g/day plant stanols for 4 weeks and showed modest but significant LDL and total cholesterol reductions.

Trust comment: Well-designed randomized double-blind placebo-controlled trial (n=70) with clear lipid endpoints and statistically significant LDL lowering.

Study Details

PMID:23786762
Participants:70
Impact:-6.3%
Trust score:4/5

Heterozygotes and controls took ~1.6 g/day plant sterols for 4 weeks; LDL fell in both groups while plant sterol levels rose and absorption decreased with compensatory synthesis increase.

Trust comment: Randomized, double-blind, crossover placebo-controlled study with direct kinetic measures; small sample but rigorous methods.

Study Details

PMID:22378727
Participants:25
Impact:decrease (~0.39 mmol/L absolute decrease in both groups)
Trust score:4/5

Mildly hypercholesterolemic Thais drank soy milk with 2 g/day plant stanols for 6 weeks and had substantial LDL and total cholesterol reductions; some fat-soluble carotenoids decreased.

Trust comment: Large (n=120), double-blind, placebo-controlled trial with clear clinically relevant LDL reductions and monitoring of vitamins; solid quality.

Study Details

PMID:22256472
Participants:120
Impact:-13.5%
Trust score:4/5

Volunteers consumed meat products enriched with plant sterols (different doses) and minerals in 3-week periods; higher-dose sterol meat reduced total cholesterol modestly.

Trust comment: Small single-blind randomized study (n=21 completed) showing modest total cholesterol reduction at higher sterol dose; limited power.

Study Details

PMID:15545047
Participants:21
Impact:-4.6% (not significant)
Trust score:3/5

Taking encapsulated phytosterol esters for 12 weeks modestly lowered total and LDL cholesterol in people with high LDL.

Trust comment: Randomized, double-blind, placebo-controlled human trial with moderate sample size; results directly from phytosterol supplementation.

Study Details

PMID:17644340
Participants:54
Impact:-5.00% (mean change from baseline)
Trust score:4/5

Adding plant sterol esters to a reduced‑fat spread in a low‑fat diet lowered blood cholesterol and related lipids in adults with mild‑to‑moderate high cholesterol.

Trust comment: Randomized double‑blind parallel trial with clear lipid endpoints and per‑protocol effect sizes reported.

Study Details

PMID:11451715
Participants:224
Impact:−7.6% (1.1 g/d), −8.1% (2.2 g/d)
Trust score:4/5

Different doses of plant stanol esters produced a dose‑dependent reduction in total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Single‑blind, within‑subject dose‑response in 22 participants; small sample but consistent dose effects.

Study Details

PMID:10736328
Participants:22
Impact:−1.7% (0.8 g/d), −5.6% (1.6 g/d), −9.7% (2.4 g/d), −10.4% (3.2 g/d)
Trust score:3/5

Short preoperative consumption of stanol or sterol spreads lowered blood cholesterol in statin‑treated patients; stanols tended to reduce arterial plant sterols.

Trust comment: Randomized double‑blind study in a small, specialized perioperative statin‑treated population; limited generalizability.

Study Details

PMID:20096545
Participants:22
Impact:decreased (statistically significant vs baseline)
Trust score:3/5

A spread with plant stanol esters (2 g/d) rapidly lowered cholesterol, hsCRP, and estimated cardiovascular risk compared with placebo.

Trust comment: Prospective randomized placebo‑controlled study with adequate sample size and clinically relevant endpoints.

Study Details

PMID:19939653
Participants:150
Impact:−16% (1 month)
Trust score:4/5

Four weeks of yoghurt with 2 g plant stanol ester in obese women lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Single-blind, placebo-controlled with reasonable sample size (n=90) though short duration (4 weeks).

Study Details

PMID:25060157
Participants:90
Impact:decreased (significant, p<0.05)
Trust score:4/5

Plant sterol esters and stanols incorporated into various foods lowered LDL cholesterol (sterol esters ~13.6% fall; stanols ~8.3% fall) and altered plasma sterol markers without reducing plasma carotenoids.

Trust comment: Randomized single-blind crossover trials with small to moderate sample sizes (22 and 15), controlled design supports credibility.

Study Details

PMID:11781675
Participants:37
Impact:reduced (sterol esters −13.6%; stanols −8.3%)
Trust score:4/5

Fat-free foods containing soy stanol-lecithin reduced single-meal cholesterol absorption substantially and, over 4 weeks, lowered total cholesterol (~10%) and LDL (~14%).

Trust comment: Randomized, double-blind parallel trial with clear endpoints though modest sample size (n=24 for chronic outcomes).

Study Details

PMID:12728215
Participants:24
Impact:reduced by ~14.3% (chronic, n=24)
Trust score:4/5

In 309 Chinese adults, daily plant-sterol–enriched milk tea (1.5–2.3 g/day) for 5 weeks reduced total cholesterol modestly and produced a non-significant trend to lower LDL.

Trust comment: Large double-blind randomized controlled trial in humans with clear, directly measured lipid outcomes.

Study Details

PMID:17617940
Participants:309
Impact:-0.17 mmol/L (2.3 g/d, p=0.06) and -0.15 mmol/L (1.5 g/d, p=0.08) (trends)
Trust score:5/5

In 68 healthy people, rye bread with 2–4 g/day plant sterols for short treatment periods lowered total and LDL cholesterol and improved apoB/apoA1 and cholesterol/HDL ratios without affecting fat‑soluble vitamins.

Trust comment: Double-blind dietary intervention in humans with objective lipid outcomes, though sample size moderate and treatment periods brief.

Study Details

PMID:21215605
Participants:68
Impact:-8.1% (2 g/d, 2 weeks) and -10.4% (4 g/d, 2 weeks; -0.33 mmol/L)
Trust score:4/5

One month of psyllium plus plant sterols lowered LDL cholesterol, shifted LDL toward larger particles, and increased LDL receptor abundance.

Trust comment: Randomized double-blind crossover with mechanistic measures; sample moderate (n=33) but results biologically plausible.

Study Details

PMID:17449576
Participants:33
Impact:-0.5 mmol/L (~-13.9%)
Trust score:4/5

Consuming low-fat dairy products with ~2 g/day plant sterols for 6 weeks reduced total and LDL cholesterol without lowering fat-soluble vitamin levels.

Trust comment: Large, multi-site double-blind randomized trial with clear, statistically significant lipid changes and safety measures reported.

Study Details

PMID:16404415
Participants:164
Impact:-10.4% (sterol group) vs -0.6% (control)
Trust score:5/5

Eating cocoa-flavanol dark chocolate bars with added sterol esters (≈2.2 g/day) for 4 weeks reduced total and LDL cholesterol and lowered systolic blood pressure at 8 weeks.

Trust comment: Double-blind, placebo-controlled crossover with 49 participants; sterols combined with cocoa flavanols so effects are partly co-interventions.

Study Details

PMID:18356327
Participants:49
Impact:-5.3%
Trust score:4/5

In 21 overweight people with high cholesterol, olive-oil-esterified plant sterols reduced LDL and (for the olive-oil formulation) decreased LDL susceptibility to peroxidation.

Trust comment: Randomized crossover in humans with 28-day periods but small sample and limited magnitude reporting.

Study Details

PMID:17559697
Participants:21
Impact:decrease (P=0.0483) vs olive oil control
Trust score:3/5

In 29 rheumatoid arthritis patients, a strict uncooked vegan diet for 2–3 months lowered total and LDL cholesterol and changed plant sterol ratios (higher sitosterol:campesterol).

Trust comment: Randomized diet intervention in humans with clear biochemical outcomes but moderate sample size and indirect relation to supplement use.

Study Details

PMID:11242480
Participants:29
Impact:decrease (significant vs control)
Trust score:3/5

In 32 adults given stearate-enriched plant sterol esters (3 g/day) for 4 weeks, LDL cholesterol fell ~11% and LDL:HDL ratio decreased ~10%.

Trust comment: Randomized, double-blind, placebo-controlled human trial with clear lipid endpoints but modest sample size and short duration.

Study Details

PMID:19535421
Participants:32
Impact:-0.42 mmol/L (≈ -11%)
Trust score:4/5

In 58 hypercholesterolemic volunteers, margarines with 2 g/day plant sterols lowered LDL (~8–9%) and rapeseed-derived sterols improved some vascular markers (E-selectin, tPAI-1).

Trust comment: Double-blind randomized crossover with 58 completers and relevant biomarker endpoints; well-designed though short treatment periods.

Study Details

PMID:25553599
Participants:58
Impact:-8 to -9% (with sterol margarines)
Trust score:4/5

Low-fat margarines containing plant stanol esters added to a low-fat diet reduced total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Randomized, double-blind parallel trial in humans with clear lipid endpoints and statistically significant results; moderate sample size.

Study Details

PMID:10075323
Participants:55
Impact:WSEM: additional -13.7% vs control; VOSEM: additional -8.6% vs control
Trust score:4/5

Daily phytostanol softgels for 28 days lowered total and LDL cholesterol in adults with high cholesterol.

Trust comment: Randomized, double-blind, placebo-controlled human trial with clear percentage changes but small sample and short duration.

Study Details

PMID:17707978
Participants:30
Impact:-9%
Trust score:4/5

Daily plant stanol ester margarine reduced total and LDL cholesterol in healthy 6-year-old children regardless of gender or apoE phenotype.

Trust comment: Well-controlled, randomized cross-over study in children with consistent effects reported; moderate sample and robust design.

Study Details

PMID:12463311
Participants:81
Impact:~-8% (overall)
Trust score:4/5

Consuming plant sterol ester-enriched salad dressings (3.6 g/d) lowered LDL and triglycerides but also reduced plasma carotenoids in mildly hypercholesterolemic adults.

Trust comment: Controlled, randomized crossover feeding study with well-measured endpoints though short duration and modest sample size.

Study Details

PMID:11876261
Participants:53
Impact:-9.7%
Trust score:4/5

Daily low-fat yoghurt containing plant stanol esters lowered LDL cholesterol within 1 week; some fat-soluble antioxidants changed.

Trust comment: Randomized parallel study with clear lipid endpoints but modest sample size and short duration (4 weeks).

Study Details

PMID:11755939
Participants:60
Impact:-13.7% (difference -0.40 mmol/L; experimental -0.34 mmol/L vs placebo +0.06 mmol/L)
Trust score:4/5

Daily spreads with microcrystalline plant sterols (1.5–3.0 g/day) lowered total and LDL cholesterol over 6 months with no apparent adverse effects on fat‑soluble vitamins.

Trust comment: Large double-blind, randomized, placebo-controlled 6‑month trial with clinically relevant endpoints and adequate sample size.

Study Details

PMID:11518201
Participants:155
Impact:-7.5% to -11.6% (≈0.46–0.62 mmol/L)
Trust score:5/5

Ezetimibe plus statin produced greater and more sustained LDL-C lowering than doubling statin dose, with persistent decreases in absorption markers (campesterol) over 52 weeks.

Trust comment: Randomized comparison over 52 weeks with relevant biomarker and clinical endpoints; moderate sample size.

Study Details

PMID:22892323
Participants:150
Impact:greater reduction maintained to 52 weeks with ezetimibe+statin (vs double-dose statin)
Trust score:4/5

In a 3‑month randomized study, adding phytosterols to canned tuna produced a significantly larger reduction in total and LDL cholesterol than tuna alone.

Trust comment: Large randomized single‑blind dietary intervention with consistent lipid outcomes, though exact effect sizes versus control not reported in the summary text.

Study Details

PMID:17594856
Participants:400
Impact:significant reduction in all groups; phytosterol group had greater reduction vs control (p<0.05)
Trust score:4/5

Milk powder with 2.5 g/day plant sterol esters lowered 'bad' (LDL) cholesterol in adults with high cholesterol over 6 weeks.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size (n=59).

Study Details

PMID:25327602
Participants:59
Impact:-7.69% vs placebo after 6 weeks (-0.33 mmol/L)
Trust score:4/5

Postmenopausal women who drank a beverage with 2 g/day plant sterols for 6 weeks had lower total and LDL cholesterol and changes in some sterol and cytokine markers.

Trust comment: Randomized double-blind crossover study measuring biochemical and inflammatory biomarkers in a defined cohort (n=38).

Study Details

PMID:30206618
Participants:38
Impact:-5.9% (129.4 to 121.7 mg/dL)
Trust score:4/5

A phytosterol-enriched rice bran oil spread consumed as part of the diet reduced total and LDL cholesterol in mildly hypercholesterolaemic adults.

Trust comment: Randomized double-blind crossover trial with adequate sample (n=80) and clear lipid outcomes.

Study Details

PMID:21320365
Participants:80
Impact:-5.6% vs standard spread
Trust score:4/5

Plant stanol (2.5 g/day) margarine for 3 weeks lowered total and LDL cholesterol and reduced triglycerides especially in subjects with high baseline TAG.

Trust comment: Randomized placebo-controlled study but small sample (n=28) and subgroup effects reported.

Study Details

PMID:19904567
Participants:28
Impact:-9.5%
Trust score:3/5

Ten-day administration of tall oil phytosterols lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Randomized crossover with mechanistic measures but short duration and small sample (n=22).

Study Details

PMID:9627377
Participants:22
Impact:≈-6% (3.2 to 3.0 mmol/L)
Trust score:3/5

Low‑fat margarine and milk providing 2.3 g/day plant sterols reduced total and LDL cholesterol in mildly hypercholesterolemic adults.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover with 46 completers; clinically relevant endpoints and clear percent changes reported.

Study Details

PMID:17719702
Participants:46
Impact:-7.7%
Trust score:4/5

Consuming 2.5 g plant stanols daily (either once or divided) lowered LDL cholesterol; HDL and triglycerides were unchanged.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover (39 subjects) with clear LDL effect and appropriate control periods.

Study Details

PMID:11002377
Participants:39
Impact:-0.29 to -0.31 mmol/L vs control
Trust score:4/5

Adding 5.1 g/day plant stanol spread to stable statin therapy further lowered total and LDL cholesterol compared with placebo spread.

Trust comment: Randomized, double‑blind, placebo‑controlled trial with 167 participants on stable statin therapy; robust, clinically relevant reductions reported.

Study Details

PMID:10867091
Participants:167
Impact:-17% (active) vs -7% (placebo); absolute -24 vs -10 mg/dL
Trust score:4/5

Low‑fat foods enriched with 1.25–5.0 g/day natural plant sterols reduced total and LDL cholesterol in mildly–moderately hypercholesterolemic adults.

Trust comment: 15‑week randomized, double‑blind, placebo‑controlled feeding trial with 71 completers; good duration and dietary control.

Study Details

PMID:11703963
Participants:71
Impact:-13% (active) vs -5% (placebo)
Trust score:4/5

Study tested plant sterol–fortified spreads on cholesterol; measured 25-OH-vitamin D and found no change, but the intervention was not vitamin D supplementation.

Trust comment: Randomized, double‑blind, placebo‑controlled design with 100 subjects and dose‑response data; credible and informative.

Study Details

PMID:10334658
Participants:100
Impact:-0.20 to -0.30 mmol/L (~6.7–9.9%)
Trust score:4/5

Adding 2 g/day plant sterol–enriched milk to a healthy diet reduced total and LDL cholesterol without worsening overall antioxidant status, though one carotenoid (cryptoxanthin) fell.

Trust comment: Randomized parallel trial with defined interventions and measured biochemical outcomes; moderate quality.

Study Details

PMID:19889524
Participants:40
Impact:-9.9%
Trust score:4/5

Six weeks of daily phytosterol-enriched low-fat fermented milk lowered total and LDL cholesterol and reduced a plasma isoprostane marker of oxidative burden.

Trust comment: Multicenter randomized double-blind design with clear lipid and oxidative marker changes over 6 weeks.

Study Details

PMID:18762410
Participants:116
Impact:-~11.3% (from 166.2 to 147.4 mg/dL)
Trust score:4/5

Three months of 2 g/day phytosterol plus healthy diet lowered total and LDL cholesterol and improved apolipoprotein ratio, with no change in LDL particle size.

Trust comment: Randomized parallel trial with adequate sample and clear lipid outcome reporting.

Study Details

PMID:21048770
Participants:75
Impact:-8.1%
Trust score:4/5

Meta-analysis of four parallel double-blind substudies (5-week each) found low-fat milk products with 2 g/day stanols modestly lowered total and LDL cholesterol.

Trust comment: Pooled randomized double-blind substudies with moderate sample but unpublished substudies and short interventions reduce confidence.

Study Details

PMID:17225918
Participants:199
Impact:statistically significant reduction (magnitude related to baseline LDL; % not uniformly reported)
Trust score:3/5

Replacing part of daily fat with sitostanol-ester margarine for one year lowered total and LDL cholesterol and was well tolerated.

Trust comment: One-year randomized double-blind trial (n=153) with clear significant cholesterol reductions and good design.

Study Details

PMID:7566021
Participants:153
Impact:-14.1% (difference vs control -21 mg/dL)
Trust score:5/5

Daily intake of a plant sterol–enriched spread for 4 weeks lowered total and LDL cholesterol and apolipoprotein B without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover (n=42) showing consistent lipid-lowering effects with plant sterol intake.

Study Details

PMID:12003257
Participants:42
Impact:-10% (−16 mg/dL)
Trust score:5/5

Checklist: - Confirm human RCT testing plant stanol (phytosterol) effect in children; - Extract main measured outcomes (total cholesterol, LDL-C, beta-carotene/LDL ratio); - Record participant count and numerical changes; assess study quality quickly. Simple summary: In a double-blind crossover trial in 6-year-old children, replacing fat with plant stanol–enriched margarine slightly lowered total and LDL cholesterol but reduced beta-carotene/LDL ratio.

Trust comment: Well-conducted double-blind randomized crossover trial in children with intention-to-treat analysis and clear numerical outcomes.

Study Details

PMID:10753249
Participants:81
Impact:-7.5%
Trust score:4/5

Checklist: - Confirm human randomized trial of plant sterol–enriched low-fat fermented milk; - Extract main outcomes (LDL-C, oxidized LDL, plasma sitosterol); - Record participant count and numeric changes and safety markers. Simple summary: In hypercholesterolemic adults, daily low-fat fermented milk with plant sterols (1.6 g/day) reduced LDL cholesterol and oxidized LDL and raised plasma sitosterol without adverse oxidative-stress signals.

Trust comment: Large randomized controlled study (n=194) with objective biochemical endpoints and clear reporting.

Study Details

PMID:17823447
Participants:194
Impact:-9.5% at 3 wk; -7.8% at 6 wk vs control
Trust score:4/5

Checklist: - Confirm human crossover trial comparing PS esters with different fatty-acid carriers (sunflower, olive, fish oil); - Extract main outcomes (LDL-C, triglycerides, PAI-1) and their numeric changes; - Note sample size, crossover design, and industry involvement when assessing trust. Simple summary: In a small crossover study, plant sterol esters carried by fish oil lowered triglycerides and PAI-1 more than vegetable-oil carriers; all PS treatments lowered cholesterol versus baseline.

Trust comment: Small, well-controlled crossover human trial (n=21) with multiple outcomes and declared industry involvement, limiting generalizability.

Study Details

PMID:17961204
Participants:21
Impact:Decreased vs baseline (effect sizes: PS-SO -0.58; PS-OO -0.55; PS-FO -0.45 mmol/L)
Trust score:3/5

Checklist: - Confirm human semirandomized double-blind crossover trial testing free plant sterols with high vs low dietary cholesterol; - Extract main outcomes (LDL-C, total cholesterol, plasma beta-sitosterol); - Note participant count and interaction results. Simple summary: In a 22-person crossover trial, plant sterol supplementation lowered cholesterol independent of dietary cholesterol level and increased plasma beta-sitosterol.

Trust comment: Small, controlled crossover RCT with clear design but limited sample size and incomplete numerical details in the provided text.

Study Details

PMID:18249205
Participants:22
Impact:Decrease with PS supplementation (magnitude not specified in abstract)
Trust score:3/5

Checklist: - Confirm human randomized crossover dietary intervention in familial hypercholesterolemia (FH); - Extract main outcomes (LDL-C response, endothelial function, LDL particle size), focusing on LDL changes by baseline sitosterol tertiles; - Record numerical LDL changes per tertile. Simple summary: In FH patients, baseline plasma sitosterol levels predicted LDL response to sitosterol-enriched diets: those with higher basal sitosterol had larger LDL reductions.

Trust comment: Randomized crossover in FH patients (n=30) with clear tertile-based LDL responses, but moderate sample size limits power.

Study Details

PMID:17440528
Participants:30
Impact:Change from low-cholesterol to low-cholesterol+PS: upper tertile -21 ± 8 mg/dL; intermediate -19 ± 7 mg/dL; lower tertile +8 ± 5 mg/dL
Trust score:3/5

In hypercholesterolemic subjects, spreads with plant sterol/stanol esters lowered LDL (~7.7–9.5%) while dietary advice to add a high-carotenoid serving maintained plasma carotenoids.

Trust comment: Double-blind randomized crossover (n=46) with clear biochemical endpoints; adequate design though sample modest.

Study Details

PMID:11756063
Participants:46
Impact:-7.7% (sterol ester), -9.5% (stanol ester)
Trust score:4/5

Phytosterol-enriched milk (2 g/day) reduced cholesterol measures in non-MetS patients (LDL ~-10.5%) but produced little or no benefit in MetS patients.

Trust comment: Randomized parallel trial but small subgroup sizes and limited power; findings plausible but sample-limited.

Study Details

PMID:21489663
Participants:48
Impact:-10.5% (non-MetS); no meaningful change (MetS)
Trust score:3/5

Daily ingestion of 2 g plant stanols lowered LDL-C (~9–10%) and ApoB (~5–9%) in Japanese subjects; response was not influenced by ApoE phenotype.

Trust comment: Randomized, placebo-controlled trial with >100 subjects and clear lipid endpoints; good quality for dietary intervention.

Study Details

PMID:12093429
Participants:105
Impact:-8.9% (E3 group), -10.4% (E4 group)
Trust score:4/5

In patients undergoing carotid surgery, cholestyramine plus sitosterol lowered LDL-C less than atorvastatin and plaques showed higher macrophage content versus high‑dose statin.

Trust comment: Randomized trial with histological endpoints in 60 patients; well-conducted but small and effects were influenced by differences in LDL‑C lowering.

Study Details

PMID:20413736
Participants:60
Impact:decrease, but smaller magnitude vs atorvastatin groups
Trust score:4/5

In 152 adults with primary hypercholesterolemia, sterol‑ester margarine lowered LDL by ~8%; combined with cerivastatin the LDL reduction was additive (~39% combined).

Trust comment: Multicenter, randomized double-blind trial with adequate sample size and clear LDL outcomes, though short duration (4 weeks).

Study Details

PMID:12356387
Participants:152
Impact:−8% with sterol-ester margarine vs regular margarine (95% CI 4%–12%)
Trust score:4/5

In 72 healthy adults, a reduced-calorie orange juice with plant sterols (2 g/day) for 8 weeks lowered LDL (~9.4%), total cholesterol (~5%), and CRP (~12%) and increased HDL.

Trust comment: Randomized trial of moderate size with clear lipid and CRP changes; 8-week duration limits long-term inference.

Study Details

PMID:17023701
Participants:72
Impact:−9.4% (P<0.001 vs baseline/placebo)
Trust score:4/5

In 112 non-hypercholesterolemic adults, consumption of stanol-ester products (vegetable or wood based) lowered LDL by ~13–15% with no change in HDL or triglycerides.

Trust comment: Controlled intervention with >100 participants; results robust for LDL lowering though population was non-hypercholesterolemic.

Study Details

PMID:10580176
Participants:112
Impact:−14.6% (vegetable oil based) and −12.8% (wood based) vs control
Trust score:4/5

- Checklist: - Confirm human study and outcomes (lipids, endothelial function). - Extract participant count and main outcomes (TC, LDL-C, FMD). - Report numeric changes, assess quality. Children with familial high cholesterol took yogurt with 2.0 g plant stanols daily; their LDL and total cholesterol fell but blood vessel function (FMD) did not improve.

Trust comment: Double-blind crossover RCT in children with clear numeric lipid and FMD results; moderate sample size.

Study Details

PMID:16647412
Participants:42
Impact:-9.2%
Trust score:4/5

- Checklist: - Confirm human intervention(s) and select top outcomes (non-HDL/LDL, TAG, VLDL particle counts). - Extract participant numbers per study and reported numeric changes. - Assess study design and report likely mechanisms discussed. Two controlled human intervention studies (metabolic syndrome and normolipidemic groups) showed that plant stanol esters lower cholesterol and, in subjects with high baseline TAG, markedly reduce triglycerides and large VLDL particles.

Trust comment: Two double-blind placebo-controlled trials with N reported and detailed lipoprotein profiling; mechanistic interpretation partly speculative.

Study Details

PMID:19856194
Participants:130
Impact:-0.44 mmol/L (−13.7%) (normolipidemic subjects)
Trust score:4/5

- Checklist: - Confirm randomized crossover feeding trial and main outcomes (LDL-C, HDL-C). - Extract completed participant count and LDL/HDL changes. - Provide quality judgement. In a controlled crossover feeding study, replacing part of the diet with a plant-sterol–enriched spread lowered LDL cholesterol more than replacing the spread with carbohydrate.

Trust comment: Randomized, controlled crossover feeding study with all foods provided; small sample but strong internal control.

Study Details

PMID:16216719
Participants:29
Impact:-20% (relative to high-saturated-fat diet; mean 4.68 → 3.76 mmol/L)
Trust score:4/5

- Checklist: - Confirm randomized crossover single-blind human trial and primary outcomes (lipids). - Extract participant count and main lipid changes. - Note study limitations (single morning dose administration). In adults with mild-to-moderate hypercholesterolemia, single morning doses of several plant sterol preparations for 29 days did not lower total or LDL cholesterol but were associated with an approximate 8% increase in HDL.

Trust comment: Randomized crossover single-blind trial with small sample and unconventional single-dose-with-breakfast design reducing generalizability.

Study Details

PMID:16549466
Participants:30
Impact:no significant change
Trust score:3/5

In a 4-week crossover double-blind study, margarine with phytosterol esters lowered blood cholesterol levels, with genotype affecting the size of the effect.

Trust comment: Well-conducted double-blind crossover RCT with moderate sample and genotype stratification, providing reliable lipid outcome data.

Study Details

PMID:12771320
Participants:60
Impact:-12% (overall); -9.5% (CETP II phenotype); non-significant in VV phenotype
Trust score:4/5

Five-week randomized double-blind trial showed cheese with 2 g/day plant stanols lowered total and LDL cholesterol compared with control cheese.

Trust comment: Randomized double-blind parallel study with full completion and clear lipid endpoints; moderate sample gives reliable effect estimates.

Study Details

PMID:16721398
Participants:67
Impact:-10.3% (-0.36 mmol/L)
Trust score:4/5

Triglycerides

17 evidences

A combined nutraceutical containing bergamot extract and phytosterols improved triglycerides, LDL-C, and insulin resistance markers versus placebo in overweight dyslipidemic subjects.

Trust comment: Well-controlled RCT but uses a multi-ingredient product, so phytosterol-specific effects cannot be isolated.

Study Details

PMID:31225673
Participants:90
Impact:decrease (significant)
Trust score:3/5

In HIV patients on HAART, phytosterol 2 g/day for 4 weeks modestly lowered LDL and total cholesterol; adding phytosterols to pravastatin did not further reduce LDL versus pravastatin alone.

Trust comment: Randomized cross-over with objective lipid measures but small sample and open-label design limit generalizability.

Study Details

PMID:26148680
Participants:33
Impact:-4.08%
Trust score:4/5

A multi-ingredient nutraceutical containing sterol esters/stanols improved fasting and post‑prandial lipid profile and reduced endothelial damage markers after 3 months versus placebo.

Trust comment: Randomized placebo-controlled trial with adequate size but uses a multi-component product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:29655700
Participants:80
Impact:decrease (p<0.05)
Trust score:3/5

In metabolic syndrome patients on a western diet, 4 g/day phytosterols for 2 months significantly reduced total cholesterol, LDL‑C, small dense LDL, apoB, and triglycerides.

Trust comment: Randomized, placebo-controlled trial with a substantial sample and clear lipid endpoints.

Study Details

PMID:21316934
Participants:108
Impact:-19.1%
Trust score:5/5

In 134 adults with impaired glucose regulation, 12-week plant sterol (1.7 g/day) supplementation decreased triglycerides and hs-CRP; combined plant sterol+omega‑3 produced additional benefits on HDL and glucose/insulin indices.

Trust comment: Randomized, double-blind, placebo-controlled 2×2 factorial trial with 134 participants and multiple metabolic endpoints; reasonably powered and well-reported.

Study Details

PMID:31043161
Participants:134
Impact:decrease with plant sterols (change from baseline ≈ −0.11 mmol/L; P<0.01 vs placebo)
Trust score:4/5

Daily spread with ~2.2 g plant sterols for 6 weeks lowered fasting triglycerides and LDL-C in individuals with or at risk of T2DM (per-protocol analysis).

Trust comment: Large, randomized, double-blind, placebo-controlled study with predefined endpoints and appropriate analyses (per-protocol reported).

Study Details

PMID:29795368
Participants:138
Impact:−8.3% (−0.20 mmol/L)
Trust score:5/5

Softgel providing 1.8 g/day esterified plant sterols/stanols reduced LDL-C, non-HDL-C and total cholesterol versus placebo in adults with primary hypercholesterolemia.

Trust comment: Randomized, double-blind crossover replication study but small sample (n=30) limits precision.

Study Details

PMID:24287284
Participants:30
Impact:no change
Trust score:4/5

In healthy middle-aged adults, daily plant stanol ester margarine reduced total cholesterol, LDL and triglycerides over 4 weeks of supplementation.

Trust comment: Randomized, double-blind but small sample and short duration limit generalizability.

Study Details

PMID:16546486
Participants:26
Impact:-18% (after 4 weeks MS)
Trust score:3/5

Adults with moderate high cholesterol drank phytosterol-enriched soy milk and had lower LDL and endothelin-1, with some lipid improvements in higher‑LDL participants.

Trust comment: Randomized, double‑blind, placebo‑controlled human trial but small sample (n=38) and short treatment periods limit generalizability.

Study Details

PMID:32455866
Participants:38
Impact:decrease (−16% in higher‑baseline LDL subgroup; no change in lower‑baseline subgroup)
Trust score:4/5

Low-dose soy protein with added beta-sitosterol given daily for 40 days lowered LDL-C and apoB but did not affect Lp(a) or oxidized LDL antibodies.

Trust comment: Small single-arm pre-post study (36 subjects) with statistically significant LDL-C and apoB changes but limited by sample size and design.

Study Details

PMID:15309453
Participants:36
Impact:-8.47 mg/dL (mean change), p = 0.358 (ns)
Trust score:3/5

Crossover trial: fish-oil–ester plant sterols lowered triglycerides markedly and plant sterol esters lowered LDL and apoB compared with control oil.

Trust comment: Small, semi-randomized single-blind crossover with multiple interventions; physiological endpoints measured but limited sample size.

Study Details

PMID:17158440
Participants:21
Impact:Markedly lower fasting and postprandial triacylglycerol with fish oil and fish-oil–plant-sterol esters vs olive oil (exact % not provided)
Trust score:3/5

A 12-week low-GI diet including 30 g soy protein and 4 g phytosterols/day lowered cholesterol and triglycerides more than a standard diet in postmenopausal women.

Trust comment: Randomized 12-week trial with matched caloric/exercise controls and clear between-group lipid reductions, moderate sample size.

Study Details

PMID:16459222
Participants:53
Impact:-44.8%
Trust score:4/5

Forty-two-day randomized double-blind trial where 1.6 g/day phytosterol yogurt reduced LDL-C ~10–12%, lowered triglycerides, and increased the proportion reaching LDL targets.

Trust comment: Multicentre randomized double-blind placebo-controlled trial with clinically relevant endpoints and good sample size.

Study Details

PMID:18193377
Participants:83
Impact:-14%
Trust score:5/5

In hypercholesterolemic adults, a low-fat spread with plant sterols reduced LDL cholesterol and triglycerides; adding EPA+DHA further reduced VLDL components.

Trust comment: Large randomized double-blind parallel trial; short treatment (4 weeks) and combined interventions limit attribution solely to plant sterols.

Study Details

PMID:26019023
Participants:282
Impact:reduced (with PS/EPA+DHA)
Trust score:4/5

Omega-3 plant sterol esters reduced triglycerides and modestly lowered diastolic BP and hsCRP but did not change LDL in mixed hyperlipidemic patients.

Trust comment: Randomized, double-blind trial with meaningful findings but substantial dropouts (24/91) and mixed intervention limits certainty.

Study Details

PMID:20617456
Participants:67
Impact:-19% (−51 mg/dL)
Trust score:3/5

Consuming plant sterol ester-enriched salad dressings (3.6 g/d) lowered LDL and triglycerides but also reduced plasma carotenoids in mildly hypercholesterolemic adults.

Trust comment: Controlled, randomized crossover feeding study with well-measured endpoints though short duration and modest sample size.

Study Details

PMID:11876261
Participants:53
Impact:-7.3%
Trust score:4/5

- Checklist: - Confirm randomized double-blind pediatric RCT and primary outcome (triglycerides). - Extract participant count and numeric triglyceride change. - Rate study trustworthiness and report concise result. Children given low-fat milk with ~2.24 g plant sterols/day had a small reduction in blood triglycerides versus control milk.

Trust comment: Double-blind randomized pediatric RCT with moderate sample size but small absolute triglyceride change reported and limited methodological detail in excerpt.

Study Details

PMID:26319820
Participants:67
Impact:-5.88 mg/dL (versus control)
Trust score:3/5

GLP-1 AUC (0–2 h)

1 evidences

Eight weeks of soymilk enriched with 2 g/day phytosterols and 10 g/day inulin increased fasting GLP-1 and GLP-1 AUC in healthy men, while insulin and glucose AUCs did not change significantly.

Trust comment: Randomized controlled subgroup (male-only) with small sample; intervention combined phytosterols and inulin so effects cannot be attributed to phytosterols alone.

Study Details

PMID:30497507
Participants:26
Impact:+11.06 pg·h/mL (from 107.97 to 119.03 pg·h/mL; p=0.003)
Trust score:3/5

Fasting GLP-1

1 evidences

Eight weeks of soymilk enriched with 2 g/day phytosterols and 10 g/day inulin increased fasting GLP-1 and GLP-1 AUC in healthy men, while insulin and glucose AUCs did not change significantly.

Trust comment: Randomized controlled subgroup (male-only) with small sample; intervention combined phytosterols and inulin so effects cannot be attributed to phytosterols alone.

Study Details

PMID:30497507
Participants:26
Impact:+6.4 pg/mL (from 43.50 to 49.90 pg/mL; p=0.002)
Trust score:3/5

TC/HDL ratio

1 evidences

In a controlled, crossover feeding study, adding plant sterols (3.3 g/day) reduced total and LDL cholesterol independently and additively with dietary fat reduction.

Trust comment: Double-blind, randomized, controlled crossover feeding study with precise interventions but small sample (n=22) limiting generalizability.

Study Details

PMID:19145455
Participants:22
Impact:-9.6% with plant sterols
Trust score:4/5

IL-6

1 evidences

A 3-month nutraceutical (contains 1.5 g phytosterols plus other agents) reduced total cholesterol, LDL-C and ApoB and lowered hs-CRP vs placebo.

Trust comment: Randomized, double-blind, placebo-controlled trial but intervention is a combination product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:31035469
Participants:40
Impact:no change
Trust score:4/5

adverse events

1 evidences

Daily soya drink fortified with 2 g phytosterols for 3 weeks produced a small but significant reduction in LDL-cholesterol versus placebo.

Trust comment: Large, double-blind RCT in a relevant population with clear LDL outcome though short duration (3 weeks).

Study Details

PMID:31642984
Participants:159
Impact:95% reported no adverse events
Trust score:4/5

Body weight

2 evidences

A 6-week diet-induced weight loss (~10.3 kg) in abdominally obese men increased markers of intestinal cholesterol absorption and decreased markers of endogenous cholesterol synthesis.

Trust comment: Well-controlled randomized trial with objective biochemical and imaging measures; moderate sample size and completed-data reporting support reliability.

Study Details

PMID:35458107
Participants:74
Impact:−10.3 kg (mean) vs control
Trust score:4/5

In overweight adults on an 8-week calorie-restricted diet, adding plant sterols to rice bran led to larger reductions in total (and a trend for LDL) cholesterol versus rice bran alone.

Trust comment: Small randomized study (n=24) with short duration and weight-loss regimen that may confound lipid changes, but randomized design supports moderate confidence.

Study Details

PMID:24955613
Participants:24
Impact:decrease ~4.7 ± 2.2 kg (both groups; no difference between groups)
Trust score:3/5

cholesterol synthesis marker (lathosterol)

1 evidences

A 6-week diet-induced weight loss (~10.3 kg) in abdominally obese men increased markers of intestinal cholesterol absorption and decreased markers of endogenous cholesterol synthesis.

Trust comment: Well-controlled randomized trial with objective biochemical and imaging measures; moderate sample size and completed-data reporting support reliability.

Study Details

PMID:35458107
Participants:74
Impact:−0.39 µmol/mmol cholesterol (significant)
Trust score:4/5

cholesterol absorption markers (campesterol, cholestanol)

1 evidences

A 6-week diet-induced weight loss (~10.3 kg) in abdominally obese men increased markers of intestinal cholesterol absorption and decreased markers of endogenous cholesterol synthesis.

Trust comment: Well-controlled randomized trial with objective biochemical and imaging measures; moderate sample size and completed-data reporting support reliability.

Study Details

PMID:35458107
Participants:74
Impact:campesterol −0.25 µmol/mmol cholesterol; cholestanol +0.18 µmol/mmol cholesterol (significant)
Trust score:4/5

total cholesterol (TC)

7 evidences

Phytosterols (2 g/day) lowered total and LDL cholesterol modestly; combining phytosterols with curcumin produced larger reductions over 4 weeks.

Trust comment: Double-blind, randomized, placebo-controlled factorial RCT with clear lipid outcomes though short duration (4 weeks).

Study Details

PMID:29291429
Participants:70
Impact:PS −4.8% from baseline; PS+curcumin −11.0% (greater reduction)
Trust score:4/5

3.0 g/d plant stanol esters for 4 weeks reduced total, LDL and non-HDL cholesterol in statin-treated adults with type 1 diabetes.

Trust comment: Randomized double-blind parallel human RCT with objective lipid endpoints but small sample (n=24) and short duration (4 wk).

Study Details

PMID:21514589
Participants:24
Impact:-9.6% vs baseline; -7.8% vs control
Trust score:4/5

1.6 g/d plant sterols in low-fat yogurt consumed as a snack modestly lowered total cholesterol and tended to lower LDL while increasing cholesterol synthesis; fat-soluble vitamins unchanged.

Trust comment: Randomized within-subject trial with controlled diets and objective biochemical outcomes, moderate sample (n=26); some effects borderline significant.

Study Details

PMID:18845709
Participants:26
Impact:Endpoint TC decreased to 5.30 mmol/L in snack phase (≈-4.2% vs control; p=0.04)
Trust score:4/5

Plant sterol esters (1.1–2.2 g/d) lowered total and LDL cholesterol in ApoE2 and ApoE3 carriers but not in ApoE4 carriers, and reduced certain serum carotenoids in some genotypes.

Trust comment: Large randomized controlled study with genotype stratification and objective measures, but responses varied by genotype limiting generalizability.

Study Details

PMID:19056656
Participants:217
Impact:Decreased in ApoE2 and ApoE3 subjects (P<0.05 vs control)
Trust score:4/5

Softgel capsules providing 1.8 g/d esterified plant sterols/stanols for 6 weeks reduced LDL, non-HDL and total cholesterol in adults with primary hypercholesterolemia.

Trust comment: Randomized, placebo-controlled crossover with objective lipid endpoints but small sample (n=28) and short treatment periods.

Study Details

PMID:22796122
Participants:28
Impact:-7.4% vs control
Trust score:4/5

Daily 2 g plant sterols in a yogurt-drink for 6–12 months significantly reduced small dense LDL-C and lowered LDL-C and total cholesterol in hypercholesterolemic children.

Trust comment: Prospective pediatric study with objective endpoints and clinically relevant follow-up but open-label design and modest completed sample (n=25) increase risk of bias.

Study Details

PMID:24887013
Participants:25
Impact:Significant decrease vs baseline (e.g., mean 7.00 → 6.34 mmol/L; p<0.001)
Trust score:3/5

Adding 2.7 g phytosterols to daily ground beef for 4 weeks lowered total and LDL cholesterol in young men with mild hypercholesterolemia.

Trust comment: Triple-blind randomized trial with clear lipid reductions but modest sample size (n=34).

Study Details

PMID:12081816
Participants:34
Impact:−9.3% from baseline (P<0.001)
Trust score:4/5

HDL & triglycerides

1 evidences

Phytosterols (2 g/day) lowered total and LDL cholesterol modestly; combining phytosterols with curcumin produced larger reductions over 4 weeks.

Trust comment: Double-blind, randomized, placebo-controlled factorial RCT with clear lipid outcomes though short duration (4 weeks).

Study Details

PMID:29291429
Participants:70
Impact:no significant change
Trust score:4/5

other lipids (TC, HDL, TG)

1 evidences

Daily soya drink fortified with 2 g phytosterols for 3 weeks produced a small but significant reduction in LDL-cholesterol versus placebo.

Trust comment: Large, double-blind RCT in a relevant population with clear LDL outcome though short duration (3 weeks).

Study Details

PMID:31642984
Participants:159
Impact:no significant change
Trust score:4/5

campesterol/5α-cholestanol ratio vs dietary phytosterol intake

1 evidences

In controlled feeding studies, the plasma campesterol/5α-cholestanol ratio best reflected dietary phytosterol intake (high correlation).

Trust comment: Controlled feeding, crossover studies with mass-spectrometry sterol measures provide robust biomarker evidence despite modest sample size.

Study Details

PMID:25668184
Participants:38
Impact:R² = 0.785 (strong correlation)
Trust score:4/5

total phytosterols/5α-cholestanol ratio vs intake

1 evidences

In controlled feeding studies, the plasma campesterol/5α-cholestanol ratio best reflected dietary phytosterol intake (high correlation).

Trust comment: Controlled feeding, crossover studies with mass-spectrometry sterol measures provide robust biomarker evidence despite modest sample size.

Study Details

PMID:25668184
Participants:38
Impact:R² = 0.767 (strong correlation)
Trust score:4/5

plasma phytosterols alone vs intake

1 evidences

In controlled feeding studies, the plasma campesterol/5α-cholestanol ratio best reflected dietary phytosterol intake (high correlation).

Trust comment: Controlled feeding, crossover studies with mass-spectrometry sterol measures provide robust biomarker evidence despite modest sample size.

Study Details

PMID:25668184
Participants:38
Impact:weaker correlation (R² ≈ 0.413)
Trust score:4/5

weight gain

1 evidences

Randomized, blinded placebo-controlled trial in hospitalized pulmonary TB patients testing beta-sitosterol plus standard therapy versus placebo.

Trust comment: Randomized, blinded placebo-controlled design is strong but sample size is small which limits precision.

Study Details

PMID:9487449
Participants:37
Impact:mean +8.9 kg (sitosterol) vs +6.1 kg (placebo); between-group difference +2.8 kg
Trust score:3/5

lymphocyte count

1 evidences

Randomized, blinded placebo-controlled trial in hospitalized pulmonary TB patients testing beta-sitosterol plus standard therapy versus placebo.

Trust comment: Randomized, blinded placebo-controlled design is strong but sample size is small which limits precision.

Study Details

PMID:9487449
Participants:37
Impact:significantly increased in sitosterol group (no absolute value reported)
Trust score:3/5

eosinophil count

1 evidences

Randomized, blinded placebo-controlled trial in hospitalized pulmonary TB patients testing beta-sitosterol plus standard therapy versus placebo.

Trust comment: Randomized, blinded placebo-controlled design is strong but sample size is small which limits precision.

Study Details

PMID:9487449
Participants:37
Impact:significantly increased in sitosterol group (no absolute value reported)
Trust score:3/5

complete response at 3 months

1 evidences

Randomized trial testing oral beta-sitosterol/sterolin mixture as an adjuvant to cryotherapy for anogenital warts in 123 patients.

Trust comment: Randomized and reasonably sized, but not placebo-controlled and used as adjuvant so attribution solely to sterols is limited.

Study Details

PMID:24838062
Participants:123
Impact:30.2% with sterol mixture vs 18.3% control (+11.9 percentage points)
Trust score:3/5

lesion-free at 6 months

1 evidences

Randomized trial testing oral beta-sitosterol/sterolin mixture as an adjuvant to cryotherapy for anogenital warts in 123 patients.

Trust comment: Randomized and reasonably sized, but not placebo-controlled and used as adjuvant so attribution solely to sterols is limited.

Study Details

PMID:24838062
Participants:123
Impact:79.4% with sterol mixture vs 61.7% control (+17.7 percentage points)
Trust score:3/5

time-to-response

1 evidences

Randomized trial testing oral beta-sitosterol/sterolin mixture as an adjuvant to cryotherapy for anogenital warts in 123 patients.

Trust comment: Randomized and reasonably sized, but not placebo-controlled and used as adjuvant so attribution solely to sterols is limited.

Study Details

PMID:24838062
Participants:123
Impact:hazard ratio 2.76 (95% CI 1.61–5.67) favoring sterol mixture
Trust score:3/5

flow-mediated dilation (FMD)

3 evidences

Double-blind RCT of a combined product (red yeast rice, phytosterols, L-tyrosol) in 50 hypercholesterolemic subjects showing improved lipids, liver enzymes and endothelial function after 8 weeks.

Trust comment: Double-blind RCT supports moderate trust, but the intervention combined phytosterols with other active compounds so effects cannot be attributed to phytosterols alone.

Study Details

PMID:28687937
Participants:50
Impact:+0.35% absolute improvement with active (P < 0.001)
Trust score:3/5

In hypercholesterolemic adults, a 12-week plant-sterol-enriched spread lowered total and LDL cholesterol and raised plasma phytosterols but did not change endothelial function (FMD).

Trust comment: Large randomized, double-blind, placebo-controlled trial with rigorous vascular measures and biochemical endpoints (well-powered and well-conducted).

Study Details

PMID:25809853
Participants:199
Impact:+0.01 percentage points (no significant change vs control)
Trust score:5/5

Three-month randomized study: plant stanol esters (2 g/day) lowered LDL-C but produced no overall change in arterial elasticity or endothelial function; subjects with low baseline values improved.

Trust comment: Large randomized trial with objective vascular and lipid endpoints; subgroup effects reported and overall vascular effects were null.

Study Details

PMID:18279553
Participants:200
Impact:No overall change; in low-baseline subgroup FMD improved from 6.9% to 8.6% (treatment) vs 6.6% to 6.8% in controls (P = 0.05)
Trust score:4/5

HDL-C

1 evidences

Randomized double-blind crossover: plant sterol–enriched spread lowered total and LDL cholesterol vs control without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover with 53 completers; robust design though modest sample size.

Study Details

PMID:11522112
Participants:53
Impact:no significant change
Trust score:4/5

Plasma phytosterols

2 evidences

Very-low-birth-weight infants given a multicomponent lipid emulsion grew better and had higher blood omega-3 levels than those given pure soybean oil; phytosterol levels were higher in the soybean-oil group.

Trust comment: Double-blind randomized controlled trial in humans with clear endpoints and reasonable sample size (96); subset measures limit some outcomes.

Study Details

PMID:24667866
Participants:96
Impact:lower vs control
Trust score:4/5

In a randomized double-blind crossover (4-week PS phase), soy milk with phytosterols (1.6 g/day) modestly lowered total cholesterol (~-5.5%) and LDL-C (~-7.6%) and raised plasma campesterol and sitosterol, with changes in synthesis/absorption markers.

Trust comment: Well-controlled randomized crossover with objective biochemical endpoints (n=38) supports moderate-high confidence for short-term lipid effects.

Study Details

PMID:35397367
Participants:38
Impact:campesterol and sitosterol increased significantly on PS feeding
Trust score:4/5

Time to blood pressure control

1 evidences

In preeclampsia patients, adding phytosterol to oral nifedipine shortened time to blood pressure control, delayed recurrence of hypertensive crisis, and reduced required dose without added adverse effects.

Trust comment: Large, double-blind, placebo-controlled randomized trial providing strong clinical evidence.

Study Details

PMID:31262189
Participants:253
Impact:shorter (significant)
Trust score:5/5

Time to next hypertensive crisis

1 evidences

In preeclampsia patients, adding phytosterol to oral nifedipine shortened time to blood pressure control, delayed recurrence of hypertensive crisis, and reduced required dose without added adverse effects.

Trust comment: Large, double-blind, placebo-controlled randomized trial providing strong clinical evidence.

Study Details

PMID:31262189
Participants:253
Impact:longer (significant)
Trust score:5/5

Required antihypertensive dose

1 evidences

In preeclampsia patients, adding phytosterol to oral nifedipine shortened time to blood pressure control, delayed recurrence of hypertensive crisis, and reduced required dose without added adverse effects.

Trust comment: Large, double-blind, placebo-controlled randomized trial providing strong clinical evidence.

Study Details

PMID:31262189
Participants:253
Impact:lower (significant)
Trust score:5/5

HOMA-IR

1 evidences

A combined nutraceutical containing bergamot extract and phytosterols improved triglycerides, LDL-C, and insulin resistance markers versus placebo in overweight dyslipidemic subjects.

Trust comment: Well-controlled RCT but uses a multi-ingredient product, so phytosterol-specific effects cannot be isolated.

Study Details

PMID:31225673
Participants:90
Impact:decrease (significant)
Trust score:3/5

Lathosterol (cholesterol synthesis marker)

2 evidences

In 34 adults, bars containing plant sterols ± glucomannan showed that the sterol+glucomannan combination lowered total and LDL cholesterol; plant sterol alone had limited effect.

Trust comment: Randomized crossover in 34 subjects with clear lipid endpoints but small sample and effects largely driven by combination with glucomannan rather than plant sterol alone.

Study Details

PMID:16391591
Participants:34
Impact:decreased after combination vs plant sterol (P<0.05)
Trust score:3/5

In patients with primary hypercholesterolemia, ezetimibe reduced phytosterol (absorption) markers, statins reduced synthesis markers, and combined therapy lowered both classes of non-cholesterol sterols.

Trust comment: Large post-hoc analysis of randomized trials with robust statistical significance, but exploratory (post-hoc) nature limits causal certainty.

Study Details

PMID:18053317
Participants:975
Impact:decreased (p<0.001)
Trust score:4/5

bone turnover markers

1 evidences

In 38 postmenopausal women, a 4-week milk drink with phytosterols plus β-cryptoxanthin lowered cholesterol and bone-turnover markers versus control.

Trust comment: Double-blind randomized crossover in 38 women with biochemical confirmation of phytosterol increases; moderate-quality, well-controlled study.

Study Details

PMID:24909799
Participants:38
Impact:decrease (significant vs control; P<0.05)
Trust score:4/5

Serum amyloid P (SAP)

1 evidences

Sub-study of a crossover RCT (32 overweight adults) showed 4 weeks of phytosterol-enriched milk reduced a pro-inflammatory plasma protein (SAP) and lowered CCL2 gene expression.

Trust comment: Proteomic sub-study of a double-blind crossover RCT (N=32) with validated molecular endpoints; sample is small but methods and validation support findings.

Study Details

PMID:28608804
Participants:32
Impact:1.21‑fold decrease in LPDP after PhyS-milk (P=0.001)
Trust score:4/5

CCL2 (MCP-1) gene expression

1 evidences

Sub-study of a crossover RCT (32 overweight adults) showed 4 weeks of phytosterol-enriched milk reduced a pro-inflammatory plasma protein (SAP) and lowered CCL2 gene expression.

Trust comment: Proteomic sub-study of a double-blind crossover RCT (N=32) with validated molecular endpoints; sample is small but methods and validation support findings.

Study Details

PMID:28608804
Participants:32
Impact:decrease (P=0.03)
Trust score:4/5

ApoB

3 evidences

In 90 randomized (85 completers) mildly hypercholesterolemic adults, an 8-week nutraceutical tablet containing phytosterols plus red yeast rice markedly lowered LDL-C and other lipids versus placebo.

Trust comment: Well-conducted double-blind RCT with 85 completers and significant lipid changes, but the product combined phytosterols with red yeast rice so effects are not attributable to phytosterols alone.

Study Details

PMID:33066334
Participants:85
Impact:LSM change −15.2 mg/dL in active group (between-group difference −17.3 mg/dL; P<0.0001)
Trust score:4/5

Two years of ezetimibe 10 mg/day in homozygous sitosterolemia markedly lowered circulating plant sterols (sitosterol, campesterol) and modestly lowered LDL-related sterols and apoB.

Trust comment: Open-label extension in a rare disease with small N but consistent, large biomarker changes and reasonable follow-up supports good internal validity.

Study Details

PMID:18822021
Participants:21
Impact:−10.1% from baseline (p<0.05)
Trust score:4/5

In 112 non-hypercholesterolemic adults, consumption of stanol-ester products (vegetable or wood based) lowered LDL by ~13–15% with no change in HDL or triglycerides.

Trust comment: Controlled intervention with >100 participants; results robust for LDL lowering though population was non-hypercholesterolemic.

Study Details

PMID:10580176
Participants:112
Impact:decrease (statistically significant vs control; exact % not provided)
Trust score:4/5

Plasma plant sterols (campesterol, sitosterol, stigmasterol)

1 evidences

In 127 hypercholesterolemic adults, probiotic L. reuteri reduced LDL-C and lowered circulating plant sterol markers (campesterol, sitosterol, stigmasterol), consistent with reduced sterol absorption.

Trust comment: Large randomized, placebo-controlled trial with clear biochemical effects on sterol markers and LDL-C, but intervention was a probiotic (indirect effect on phytosterol handling), not phytosterol supplementation.

Study Details

PMID:22990854
Participants:127
Impact:campesterol −41.5%; sitosterol −34.2%; stigmasterol −40.7% versus placebo
Trust score:3/5

High-sensitivity CRP (inflammation)

1 evidences

In 127 hypercholesterolemic adults, probiotic L. reuteri reduced LDL-C and lowered circulating plant sterol markers (campesterol, sitosterol, stigmasterol), consistent with reduced sterol absorption.

Trust comment: Large randomized, placebo-controlled trial with clear biochemical effects on sterol markers and LDL-C, but intervention was a probiotic (indirect effect on phytosterol handling), not phytosterol supplementation.

Study Details

PMID:22990854
Participants:127
Impact:reduction by 1.05 mg/L versus placebo (P=0.005)
Trust score:3/5

hs-CRP (inflammation)

1 evidences

In 134 adults with impaired glucose regulation, 12-week plant sterol (1.7 g/day) supplementation decreased triglycerides and hs-CRP; combined plant sterol+omega‑3 produced additional benefits on HDL and glucose/insulin indices.

Trust comment: Randomized, double-blind, placebo-controlled 2×2 factorial trial with 134 participants and multiple metabolic endpoints; reasonably powered and well-reported.

Study Details

PMID:31043161
Participants:134
Impact:decrease with plant sterols (change from baseline ≈ −0.05 mg/L vs placebo; P<0.05)
Trust score:4/5

muscle campesterol concentration

1 evidences

High-dose simvastatin or atorvastatin changed muscle sterol content and, with simvastatin, reduced muscle ubiquinone and mitochondrial enzyme activities.

Trust comment: Randomized controlled human trial but small group sizes for enzyme assays and indirect relation to phytosterol exposure.

Study Details

PMID:16003294
Participants:48
Impact:simvastatin: +95% (21.1→41.2 nmol/g); atorvastatin: +77.9% (22.6→40.0 nmol/g)
Trust score:3/5

muscle ubiquinone concentration

1 evidences

High-dose simvastatin or atorvastatin changed muscle sterol content and, with simvastatin, reduced muscle ubiquinone and mitochondrial enzyme activities.

Trust comment: Randomized controlled human trial but small group sizes for enzyme assays and indirect relation to phytosterol exposure.

Study Details

PMID:16003294
Participants:48
Impact:simvastatin: −33.5% (39.7→26.4 nmol/g)
Trust score:3/5

respiratory chain and citrate synthase activities

1 evidences

High-dose simvastatin or atorvastatin changed muscle sterol content and, with simvastatin, reduced muscle ubiquinone and mitochondrial enzyme activities.

Trust comment: Randomized controlled human trial but small group sizes for enzyme assays and indirect relation to phytosterol exposure.

Study Details

PMID:16003294
Participants:48
Impact:decreased (observed in simvastatin-treated subset)
Trust score:3/5

apo-B

2 evidences

A 3-month nutraceutical (contains 1.5 g phytosterols plus other agents) reduced total cholesterol, LDL-C and ApoB and lowered hs-CRP vs placebo.

Trust comment: Randomized, double-blind, placebo-controlled trial but intervention is a combination product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:31035469
Participants:40
Impact:−13.5% at 3 months
Trust score:4/5

In a controlled, crossover feeding study, adding plant sterols (3.3 g/day) reduced total and LDL cholesterol independently and additively with dietary fat reduction.

Trust comment: Double-blind, randomized, controlled crossover feeding study with precise interventions but small sample (n=22) limiting generalizability.

Study Details

PMID:19145455
Participants:22
Impact:-6.1% with plant sterols
Trust score:4/5

hs-CRP

3 evidences

A 3-month nutraceutical (contains 1.5 g phytosterols plus other agents) reduced total cholesterol, LDL-C and ApoB and lowered hs-CRP vs placebo.

Trust comment: Randomized, double-blind, placebo-controlled trial but intervention is a combination product so effects cannot be attributed solely to phytosterols.

Study Details

PMID:31035469
Participants:40
Impact:decreased (statistically significant)
Trust score:4/5

Incorporating phytosterols (2 g/d) in a cocoa cream for 4 weeks reduced LDL-C and improved inflammatory/oxidative biomarkers (hsCRP, oxLDL) compared with control.

Trust comment: Well-controlled, double-blind multi-arm RCT with adequate sample; phytosterols were one component of tested formulations.

Study Details

PMID:22383996
Participants:113
Impact:LMN: −33.4% (−0.96 mg/L)
Trust score:4/5

In hyperlipidemic adults, combined n‑3 PUFA and plant sterols for 3 weeks lowered inflammation markers and overall cardiovascular risk.

Trust comment: Randomized double-blind 2x2 factorial RCT in humans; well-designed but short duration and combined treatment makes isolating plant sterol effect less certain.

Study Details

PMID:18977480
Participants:60
Impact:-39% (P=0.009)
Trust score:4/5

Cholesterol absorption

10 evidences

Controlled feeding trials showed that low- and moderate-fat plant sterol–fortified soymilks reduced total and LDL cholesterol (≈10–15%) versus 1% dairy milk; moderate-fat soymilk also reduced cholesterol absorption and triglycerides.

Trust comment: Well-controlled randomized crossover feeding trials with measured cholesterol kinetics and significant lipid effects, though two separate study groups (n=33 and n=23) and short duration.

Study Details

PMID:19843338
Participants:33
Impact:Moderate-fat PS soymilk: -27% (AUC of 13C-cholesterol enrichment)
Trust score:4/5

Plant sterol (2 g/day) lowered LDL cholesterol variably; genetic variants (CYP7A1 and APOE) influenced the magnitude of LDL lowering.

Trust comment: Randomized crossover trial with genotype stratification and measured metabolic endpoints, but moderate sample size and single-blind design.

Study Details

PMID:26333513
Participants:63
Impact:decreased with plant sterol consumption (magnitude not specified)
Trust score:4/5

In an 8-week randomized trial plant sterols (with or without exercise) reduced cholesterol absorption and, when combined with exercise, produced favorable lipid changes including lower LDL.

Trust comment: Randomized, parallel-arm human trial (n=84) with direct measures of cholesterol kinetics; moderate duration (8 weeks).

Study Details

PMID:17196519
Participants:84
Impact:−16% (combination group) and −18% (plant sterol group) vs control
Trust score:4/5

In a randomized crossover trial in men, both free and esterified plant sterols reduced cholesterol absorption (~60%) and lowered beta-carotene (~50%) and alpha-tocopherol (~20%) bioavailability; esters had larger reductions than free sterols.

Trust comment: Double-blind randomized crossover with metabolic measures and standardized diet, though small sample of men only.

Study Details

PMID:15213045
Participants:26
Impact:≈−60% (both forms)
Trust score:4/5

Single‑meal isotope absorption tests showed micellar (water‑dispersible) phytosterols significantly reduce intestinal cholesterol absorption at doses as low as 300–500 mg.

Trust comment: Crossover absorption study with 24 healthy adults and isotope tracer method; robust for measuring absorption though small sample.

Study Details

PMID:16127299
Participants:24
Impact:-23.3% (300 mg), -32.0% (500 mg) vs placebo; 200 mg trend only (p=0.052)
Trust score:4/5

In a 3-period crossover in healthy adults, 2 g/day plant sterols reduced cholesterol absorption but did not significantly lower LDL due to a compensatory increase in synthesis.

Trust comment: Randomized, double-blind crossover with isotope measures of absorption/synthesis (n=49); mechanistic and well-controlled.

Study Details

PMID:28112077
Participants:49
Impact:-6% (P=0.0004)
Trust score:4/5

Fat-free foods containing soy stanol-lecithin reduced single-meal cholesterol absorption substantially and, over 4 weeks, lowered total cholesterol (~10%) and LDL (~14%).

Trust comment: Randomized, double-blind parallel trial with clear endpoints though modest sample size (n=24 for chronic outcomes).

Study Details

PMID:12728215
Participants:24
Impact:reduced (acute tests: −32.1% beverage, −38.2% egg whites)
Trust score:4/5

In 40 mildly hypercholesterolemic adults, oat beta-glucan reduced LDL by 5.0% and adding 1.5 g plant stanols reduced LDL by 9.6% vs control over 4 weeks.

Trust comment: Randomized controlled 3-period crossover (n=40) with clear biomarker changes; modest size but robust within-subject design.

Study Details

PMID:17311944
Participants:40
Impact:decreased (plant stanols, P<0.001)
Trust score:4/5

Daily plant stanol ester margarine reduced total and LDL cholesterol in healthy 6-year-old children regardless of gender or apoE phenotype.

Trust comment: Well-controlled, randomized cross-over study in children with consistent effects reported; moderate sample and robust design.

Study Details

PMID:12463311
Participants:81
Impact:decreased (no % reported); cholesterol synthesis increased in apoE4+ children
Trust score:4/5

In 26 hyperlipidemic subjects undergoing repeated plant sterol phases, some individuals showed little cholesterol absorption reduction and were non-responders; common SNPs did not explain most non-responsiveness.

Trust comment: Small, focused study with genetic analyses; provides plausible mechanistic insight but limited by small sample size.

Study Details

PMID:18641716
Participants:26
Impact:Non-responders: -7.7% ±10.8% vs top responders: -22.1% ±8.8% (after PS phases vs control)
Trust score:3/5

oxidized LDL

3 evidences

In healthy Japanese volunteers, daily plant stanol ester spread modestly lowered total and LDL cholesterol and markedly reduced oxidized LDL over the trial period.

Trust comment: Randomized, placebo-controlled trial with 105 participants; short duration but well-controlled and directly tests plant stanol-containing product.

Study Details

PMID:12679174
Participants:105
Impact:-20% (2 g/d) and -19% (3 g/d)
Trust score:4/5

In medicated secondary prevention patients, a low-fat diet that included 2 g/day phytosterols (TLCD) decreased LDL and oxidized LDL compared with a Mediterranean diet, but diets differed in multiple components.

Trust comment: Randomized dietary comparison in medicated patients (n=40) but phytosterols were part of a broader dietary intervention, limiting attribution to phytosterols alone.

Study Details

PMID:21890081
Participants:40
Impact:decreased with TLCD versus Mediterranean diet
Trust score:3/5

Checklist: - Confirm human randomized trial of plant sterol–enriched low-fat fermented milk; - Extract main outcomes (LDL-C, oxidized LDL, plasma sitosterol); - Record participant count and numeric changes and safety markers. Simple summary: In hypercholesterolemic adults, daily low-fat fermented milk with plant sterols (1.6 g/day) reduced LDL cholesterol and oxidized LDL and raised plasma sitosterol without adverse oxidative-stress signals.

Trust comment: Large randomized controlled study (n=194) with objective biochemical endpoints and clear reporting.

Study Details

PMID:17823447
Participants:194
Impact:Reduced (PS group -1.73 U/L vs control +1.40 U/L; P < 0.05)
Trust score:4/5

grade 2–3 radiation dermatitis

1 evidences

Topical β-sitosterol (Mebo) vs trolamine (Biafine) during breast radiotherapy; Mebo reduced severe itch and pain but did not change dermatitis grade.

Trust comment: Prospective randomized phase III trial with reasonable sample size; open-label but outcomes were standard and reported with statistical testing.

Study Details

PMID:29889137
Participants:161
Impact:no significant difference
Trust score:4/5

severe pruritus

1 evidences

Topical β-sitosterol (Mebo) vs trolamine (Biafine) during breast radiotherapy; Mebo reduced severe itch and pain but did not change dermatitis grade.

Trust comment: Prospective randomized phase III trial with reasonable sample size; open-label but outcomes were standard and reported with statistical testing.

Study Details

PMID:29889137
Participants:161
Impact:-11.2 percentage points (14.1% vs 2.9%)
Trust score:4/5

severe local skin pain

1 evidences

Topical β-sitosterol (Mebo) vs trolamine (Biafine) during breast radiotherapy; Mebo reduced severe itch and pain but did not change dermatitis grade.

Trust comment: Prospective randomized phase III trial with reasonable sample size; open-label but outcomes were standard and reported with statistical testing.

Study Details

PMID:29889137
Participants:161
Impact:-10.1 percentage points (11.5% vs 1.4%)
Trust score:4/5

liver:spleen attenuation ratio (hepatic steatosis)

1 evidences

NAFLD patients received phytosterol esters ± omega-3; combination tended to improve liver attenuation and significantly reduced inflammatory marker TGF-β and lipids.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size, though some outcomes were borderline and combined-intervention complicates attribution to phytosterols alone.

Study Details

PMID:32054543
Participants:96
Impact:+36% (PS+FO group; P=0.083 vs baseline)
Trust score:4/5

Transforming growth factor‑β (TGF‑β)

1 evidences

NAFLD patients received phytosterol esters ± omega-3; combination tended to improve liver attenuation and significantly reduced inflammatory marker TGF-β and lipids.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size, though some outcomes were borderline and combined-intervention complicates attribution to phytosterols alone.

Study Details

PMID:32054543
Participants:96
Impact:significantly decreased (PS+FO > placebo; P=0.032 vs PO)
Trust score:4/5

triglycerides and total cholesterol

1 evidences

NAFLD patients received phytosterol esters ± omega-3; combination tended to improve liver attenuation and significantly reduced inflammatory marker TGF-β and lipids.

Trust comment: Randomized double-blind placebo-controlled trial with clear endpoints and moderate sample size, though some outcomes were borderline and combined-intervention complicates attribution to phytosterols alone.

Study Details

PMID:32054543
Participants:96
Impact:TAG -11.57%, total cholesterol -9.55% (PS+FO group vs baseline)
Trust score:4/5

wound surface area (WSA)

1 evidences

MEBO ointment (contains β-sitosterol) improved pressure-ulcer healing, reduced wound area, PUSH score, pain, and increased complete healing rate versus placebo.

Trust comment: Multicenter randomized controlled trial with blinded assessors and ITT analysis, moderate sample size though no long-term follow-up.

Study Details

PMID:28723796
Participants:72
Impact:adjusted mean difference vs placebo: -6.0 (units) at 2 months
Trust score:4/5

PUSH score

1 evidences

MEBO ointment (contains β-sitosterol) improved pressure-ulcer healing, reduced wound area, PUSH score, pain, and increased complete healing rate versus placebo.

Trust comment: Multicenter randomized controlled trial with blinded assessors and ITT analysis, moderate sample size though no long-term follow-up.

Study Details

PMID:28723796
Participants:72
Impact:-2.6 points (difference at 2 months)
Trust score:4/5

pain (VAS) / complete healing rate

1 evidences

MEBO ointment (contains β-sitosterol) improved pressure-ulcer healing, reduced wound area, PUSH score, pain, and increased complete healing rate versus placebo.

Trust comment: Multicenter randomized controlled trial with blinded assessors and ITT analysis, moderate sample size though no long-term follow-up.

Study Details

PMID:28723796
Participants:72
Impact:VAS -2.9 points; complete healing 50.0% vs 16.7% (absolute +33.3 percentage points)
Trust score:4/5

C-reactive protein (CRP)

1 evidences

Replacing usual cooking oil with plant sterol–enriched palm oil for 8 weeks lowered total and LDL cholesterol in hyperlipidemic adults; CRP showed a small rise vs baseline but no significant between-group change.

Trust comment: Double-blind randomized controlled trial (100 completers) with clear lipid outcomes; moderate sample and short duration limit long-term inference.

Study Details

PMID:39408337
Participants:100
Impact:small increase vs baseline; no significant between-group change (p=0.062)
Trust score:4/5

cholestasis incidence

1 evidences

Randomized trial in preterm infants showing vegetable-oil based lipid emulsions raise plasma phytosterols; cholestasis was rare.

Trust comment: Large randomized clinical trial with objective GC‑MS measurements; strong methodology though clinical liver outcomes were infrequent.

Study Details

PMID:23761482
Participants:144
Impact:3 cases total (3/144 = 2.1%), no difference in 6‑week liver function overall
Trust score:4/5

Anti-COVID-19 Spike IgM

1 evidences

Overweight/obese adults consuming 4 g/day plant stanol ester around COVID-19 vaccination had larger anti-Spike IgM responses (and higher IgG in those who seroconverted) and reduced stimulated cytokine responses, without LDL changes.

Trust comment: Double-blind randomized placebo-controlled trial showing immune effects of plant stanol in a small overweight/obese cohort, independent of LDL changes.

Study Details

PMID:38278364
Participants:32
Impact:+139% difference at 2 weeks post-vaccination (31.2 BAU/mL)
Trust score:4/5

Anti-COVID-19 Spike IgG (in seroconverted subjects)

1 evidences

Overweight/obese adults consuming 4 g/day plant stanol ester around COVID-19 vaccination had larger anti-Spike IgM responses (and higher IgG in those who seroconverted) and reduced stimulated cytokine responses, without LDL changes.

Trust comment: Double-blind randomized placebo-controlled trial showing immune effects of plant stanol in a small overweight/obese cohort, independent of LDL changes.

Study Details

PMID:38278364
Participants:32
Impact:+71.3 BAU/mL (Group P = 0.043)
Trust score:4/5

Stimulated cytokine concentrations (proinflammatory/Th1/Th17/Th2)

1 evidences

Overweight/obese adults consuming 4 g/day plant stanol ester around COVID-19 vaccination had larger anti-Spike IgM responses (and higher IgG in those who seroconverted) and reduced stimulated cytokine responses, without LDL changes.

Trust comment: Double-blind randomized placebo-controlled trial showing immune effects of plant stanol in a small overweight/obese cohort, independent of LDL changes.

Study Details

PMID:38278364
Participants:32
Impact:Decreased across domains in plant stanol group
Trust score:4/5

Augmentation index (AI) / arterial stiffness (small arteries)

1 evidences

Six months of plant stanol ester (~3 g/day) reduced LDL (~10%) and non-HDL cholesterol and improved arterial stiffness in small arteries (AI) and prevented progression of large-artery stiffness (CAVI) in men.

Trust comment: Well-conducted randomized, double-blind parallel trial with vascular and lipid endpoints in 92 completers showing LDL lowering and improvements in surrogate vascular measures.

Study Details

PMID:23841572
Participants:92
Impact:Reduced vs control (group difference p=0.046); CAVI progression prevented in men (p=0.023)
Trust score:4/5

Plasma phytosterol concentration

1 evidences

Randomized trial in preterm infants showing vegetable-oil based lipid emulsions raise plasma phytosterols; cholestasis was rare.

Trust comment: Large randomized clinical trial with objective GC‑MS measurements; strong methodology though clinical liver outcomes were infrequent.

Study Details

PMID:23761482
Participants:144
Impact:higher with 100% soybean-oil emulsion (S) and lowest with MOSF; intake correlated with plasma levels
Trust score:4/5

Plasma oxyphytosterols

1 evidences

After consuming plant sterol or stanol margarine, individuals showed stable and person-specific plasma oxyphytosterol levels; some people are consistent 'high' or 'low' oxidizers.

Trust comment: Controlled dietary interventions and biochemical assays in 43 subjects support reliability, but observational components limit causal inference about determinants of oxidizer status.

Study Details

PMID:23500537
Participants:43
Impact:No overall increase after plant sterol margarine (3 g/day); concentrations remained relatively stable and varied between individuals (identification of high vs low oxidizers)
Trust score:4/5

oxLDL

1 evidences

After consuming plant sterol or stanol margarine, individuals showed stable and person-specific plasma oxyphytosterol levels; some people are consistent 'high' or 'low' oxidizers.

Trust comment: Controlled dietary interventions and biochemical assays in 43 subjects support reliability, but observational components limit causal inference about determinants of oxidizer status.

Study Details

PMID:23500537
Participants:43
Impact:Correlated with oxyphytosterol status (high vs low)
Trust score:4/5

plasma total antioxidant capacity

1 evidences

Giving 4 g/day phytosterols in yogurt to people with metabolic syndrome for 2 months did not change plasma antioxidant capacity.

Trust comment: Large, randomized, placebo-controlled parallel trial directly testing phytosterols on the outcome with adequate sample size.

Study Details

PMID:22816679
Participants:108
Impact:no change after 2 months (no difference between groups)
Trust score:4/5

LDL cholesterol (overall, genotype-specific)

1 evidences

Plant sterol (2 g/day) lowered LDL cholesterol variably; genetic variants (CYP7A1 and APOE) influenced the magnitude of LDL lowering.

Trust comment: Randomized crossover trial with genotype stratification and measured metabolic endpoints, but moderate sample size and single-blind design.

Study Details

PMID:26333513
Participants:63
Impact:CYP7A1 T/T: -0.05 ± 0.07 mmol/L (n=20, no response); G/T: -0.22 ± 0.06 mmol/L (n=35); G/G: -0.46 ± 0.12 mmol/L (n=8); APOE ɛ3: -0.13 ± 0.05 mmol/L (n=40); APOE ɛ4: -0.31 ± 0.07 mmol/L (n=23)
Trust score:4/5

Cholesterol fractional synthesis rate

2 evidences

Plant sterol (2 g/day) lowered LDL cholesterol variably; genetic variants (CYP7A1 and APOE) influenced the magnitude of LDL lowering.

Trust comment: Randomized crossover trial with genotype stratification and measured metabolic endpoints, but moderate sample size and single-blind design.

Study Details

PMID:26333513
Participants:63
Impact:higher in high-synthesis phenotype; placebo vs PS — high group 9.16% → 9.74%, low group 5.72% → 7.10%
Trust score:4/5

1.6 g/d plant sterols in low-fat yogurt consumed as a snack modestly lowered total cholesterol and tended to lower LDL while increasing cholesterol synthesis; fat-soluble vitamins unchanged.

Trust comment: Randomized within-subject trial with controlled diets and objective biochemical outcomes, moderate sample (n=26); some effects borderline significant.

Study Details

PMID:18845709
Participants:26
Impact:+25.8% (snack) and +19.5% (meal) vs control
Trust score:4/5

serum progesterone

1 evidences

In healthy volunteers consuming margarine with ~8.6 g/day phytosterols, total and LDL cholesterol fell substantially with no biologically important adverse effects on gut flora or female sex hormones.

Trust comment: Randomized, placebo-controlled dietary study under controlled conditions but small sample size; primary cholesterol effects robust.

Study Details

PMID:10654588
Participants:24
Impact:decreased (P=0.021) — authors deemed not biologically relevant
Trust score:4/5

serum TNF-α

1 evidences

In a 12-month randomized placebo-controlled trial, freshwater clam extract (contains phytosterols) significantly lowered serum TNF-α after 6 months and the reduction persisted 6 months after stopping the supplement.

Trust comment: Randomized double-blind placebo-controlled trial with 12-month follow-up but modest sample size (n=36); FCE contains phytosterols among other actives.

Study Details

PMID:35447934
Participants:36
Impact:6.72 ± 4.20 → 2.37 ± 3.43 pg/mL at 6 months (−~64.7%); 1.64 ± 4.08 pg/mL at 12 months
Trust score:4/5

glycemia (Glucose AC / HbA1c)

1 evidences

In a 12-month randomized placebo-controlled trial, freshwater clam extract (contains phytosterols) significantly lowered serum TNF-α after 6 months and the reduction persisted 6 months after stopping the supplement.

Trust comment: Randomized double-blind placebo-controlled trial with 12-month follow-up but modest sample size (n=36); FCE contains phytosterols among other actives.

Study Details

PMID:35447934
Participants:36
Impact:no significant change (stable)
Trust score:4/5

safety labs (ALT/AST/CRE/BUN/UA/ALB)

1 evidences

In a 12-month randomized placebo-controlled trial, freshwater clam extract (contains phytosterols) significantly lowered serum TNF-α after 6 months and the reduction persisted 6 months after stopping the supplement.

Trust comment: Randomized double-blind placebo-controlled trial with 12-month follow-up but modest sample size (n=36); FCE contains phytosterols among other actives.

Study Details

PMID:35447934
Participants:36
Impact:no significant changes; no severe side effects reported
Trust score:4/5

HDL-C ↔ ApoA1 correlation

1 evidences

3-week randomized double-blind trial: sterol-enriched milk lowered LDL cholesterol and showed strong HDL–ApoA1 association.

Trust comment: Small randomized double-blind RCT (n=35) but very short duration (3 weeks) and modest sample size limit generalizability.

Study Details

PMID:25561147
Participants:35
Impact:strong positive correlation (r=0.846 baseline; r=0.903 end)
Trust score:3/5

plasma plant sterol concentrations

1 evidences

In 84 sedentary adults with high cholesterol, 8 weeks of plant sterol supplementation lowered total cholesterol and absolute LDL and increased blood plant-sterol markers; combining sterols with exercise gave the best lipid changes.

Trust comment: Randomized, placebo-controlled 8‑week trial in humans with clear lipid outcomes, moderate sample size.

Study Details

PMID:15531661
Participants:84
Impact:increased (lathosterol, campesterol, beta-sitosterol; P<0.05)
Trust score:4/5

weight z score

1 evidences

Very-low-birth-weight infants given a multicomponent lipid emulsion grew better and had higher blood omega-3 levels than those given pure soybean oil; phytosterol levels were higher in the soybean-oil group.

Trust comment: Double-blind randomized controlled trial in humans with clear endpoints and reasonable sample size (96); subset measures limit some outcomes.

Study Details

PMID:24667866
Participants:96
Impact:increased vs control
Trust score:4/5

head circumference z score

1 evidences

Very-low-birth-weight infants given a multicomponent lipid emulsion grew better and had higher blood omega-3 levels than those given pure soybean oil; phytosterol levels were higher in the soybean-oil group.

Trust comment: Double-blind randomized controlled trial in humans with clear endpoints and reasonable sample size (96); subset measures limit some outcomes.

Study Details

PMID:24667866
Participants:96
Impact:increased vs control
Trust score:4/5

plasma EPA and DHA

1 evidences

Very-low-birth-weight infants given a multicomponent lipid emulsion grew better and had higher blood omega-3 levels than those given pure soybean oil; phytosterol levels were higher in the soybean-oil group.

Trust comment: Double-blind randomized controlled trial in humans with clear endpoints and reasonable sample size (96); subset measures limit some outcomes.

Study Details

PMID:24667866
Participants:96
Impact:increased vs control
Trust score:4/5

phytosterol intake from foods

1 evidences

In high cardiovascular risk subjects, increasing phytosterols from natural foods (nuts) raised phytosterol intake and was associated with lower LDL cholesterol and improved LDL/HDL ratio.

Trust comment: Substudy within a larger randomized dietary trial (PREDIMED) with 106 participants; reasonable design though observational components limit causality.

Study Details

PMID:19412676
Participants:106
Impact:+158 mg/day (Mediterranean diet with nuts vs low-fat)
Trust score:4/5

plasma sitosterol (and sum phytosterols)

1 evidences

In hypercholesterolemic adults, a 12-week plant-sterol-enriched spread lowered total and LDL cholesterol and raised plasma phytosterols but did not change endothelial function (FMD).

Trust comment: Large randomized, double-blind, placebo-controlled trial with rigorous vascular measures and biochemical endpoints (well-powered and well-conducted).

Study Details

PMID:25809853
Participants:199
Impact:sitosterol +77.9%; sum phytosterols +41.6% vs control
Trust score:5/5

office diastolic blood pressure

1 evidences

In hypercholesterolemic adults, a 12-week plant-sterol-enriched spread lowered total and LDL cholesterol and raised plasma phytosterols but did not change endothelial function (FMD).

Trust comment: Large randomized, double-blind, placebo-controlled trial with rigorous vascular measures and biochemical endpoints (well-powered and well-conducted).

Study Details

PMID:25809853
Participants:199
Impact:-1.4 mm Hg vs control
Trust score:5/5

IL-6, IL-8, TNF-α production (LPS-stimulated PBMC and whole blood)

1 evidences

Four-week crossover consumption of oat beta-glucan with or without plant stanols did not change LPS-stimulated IL-6, IL-8, TNF-α, or hs-CRP; only minimal gene expression changes (3/84 genes) after plant stanol ester.

Trust comment: Randomized crossover in 42 subjects with appropriate assays; moderate sample size for inflammatory endpoints.

Study Details

PMID:18979504
Participants:42
Impact:no change between treatments
Trust score:4/5

High-sensitivity CRP

1 evidences

Four-week crossover consumption of oat beta-glucan with or without plant stanols did not change LPS-stimulated IL-6, IL-8, TNF-α, or hs-CRP; only minimal gene expression changes (3/84 genes) after plant stanol ester.

Trust comment: Randomized crossover in 42 subjects with appropriate assays; moderate sample size for inflammatory endpoints.

Study Details

PMID:18979504
Participants:42
Impact:no change
Trust score:4/5

Atherosclerosis-related gene expression in PBMC

1 evidences

Four-week crossover consumption of oat beta-glucan with or without plant stanols did not change LPS-stimulated IL-6, IL-8, TNF-α, or hs-CRP; only minimal gene expression changes (3/84 genes) after plant stanol ester.

Trust comment: Randomized crossover in 42 subjects with appropriate assays; moderate sample size for inflammatory endpoints.

Study Details

PMID:18979504
Participants:42
Impact:minimal change (3 of 84 genes differentially expressed after plant stanol ester)
Trust score:4/5

HDL cholesterol and triacylglycerol

1 evidences

Yoghurt enriched with 1–2 g/d plant sterols lowered total and LDL cholesterol in a dose-dependent manner over the study periods; HDL and triglycerides were unchanged.

Trust comment: Randomized crossover design and significant lipid effects reported, but small sample and some outcomes not numerically detailed in abstract.

Study Details

PMID:11502237
Participants:30
Impact:no change
Trust score:4/5

Triglycerides (TGs)

1 evidences

Softgel capsules providing 1.8 g/d esterified plant sterols/stanols for 6 weeks reduced LDL, non-HDL and total cholesterol in adults with primary hypercholesterolemia.

Trust comment: Randomized, placebo-controlled crossover with objective lipid endpoints but small sample (n=28) and short treatment periods.

Study Details

PMID:22796122
Participants:28
Impact:-9.1% vs control
Trust score:4/5

Apolipoprotein B (apoB)

2 evidences

Low-dose soy protein with added beta-sitosterol given daily for 40 days lowered LDL-C and apoB but did not affect Lp(a) or oxidized LDL antibodies.

Trust comment: Small single-arm pre-post study (36 subjects) with statistically significant LDL-C and apoB changes but limited by sample size and design.

Study Details

PMID:15309453
Participants:36
Impact:-7.06 mg/dL (mean change), p = 0.016
Trust score:3/5

Daily dressing containing 800 mg plant sterol for 12 weeks reduced total cholesterol, LDL-C and ApoB versus placebo with no adverse events reported.

Trust comment: Placebo-controlled double-blind trial in 59 subjects showing significant lipid reductions though numeric magnitudes not reported in abstract.

Study Details

PMID:18075221
Participants:59
Impact:decreased (significant at 8 and 12 weeks)
Trust score:4/5

Other measured biomarkers

1 evidences

A novel phytosterol ester emulsion (1.5 g/day) given as capsules reduced LDL-C by ~10% over one month compared with placebo in a remote crossover trial.

Trust comment: Randomized double-blind crossover design with objective lab measures but small sample and compliance limitations in a remote study.

Study Details

PMID:31491873
Participants:32
Impact:No significant changes after multiple-test correction (e.g., fasting glucose, hsCRP, liver enzymes)
Trust score:4/5

Apolipoprotein B (apoB) and lipoprotein particle number

1 evidences

Cookies containing psyllium plus 2.6 g/day plant sterols for 4 weeks reduced total and LDL cholesterol and decreased apoB and numbers of atherogenic lipoprotein subfractions.

Trust comment: Randomized, double-blind crossover placebo-controlled study with clear lipid changes but modest sample size and short duration.

Study Details

PMID:16988115
Participants:33
Impact:Decreased apoB (P < 0.01) and reduced IDL/LDL/HDL small subfraction particle numbers (P < 0.05)
Trust score:4/5

beta-carotene concentration

1 evidences

Eating stanol-ester margarines had little overall effect on measured blood carotenoids over 8 weeks.

Trust comment: Randomized double-blind human trial with 55 completers but industry funding and modest sample size may bias results.

Study Details

PMID:10602355
Participants:55
Impact:decreased (significant)
Trust score:3/5

alpha-carotene concentration

1 evidences

Eating stanol-ester margarines had little overall effect on measured blood carotenoids over 8 weeks.

Trust comment: Randomized double-blind human trial with 55 completers but industry funding and modest sample size may bias results.

Study Details

PMID:10602355
Participants:55
Impact:no significant change
Trust score:3/5

lycopene concentration

1 evidences

Eating stanol-ester margarines had little overall effect on measured blood carotenoids over 8 weeks.

Trust comment: Randomized double-blind human trial with 55 completers but industry funding and modest sample size may bias results.

Study Details

PMID:10602355
Participants:55
Impact:no significant change
Trust score:3/5

CoQ10 AUC (0-10h)

1 evidences

CoQ10 formulated with low-dose soybean phytosterols showed similar bioavailability to a generic CoQ10 product in healthy men.

Trust comment: Randomized cross-over in healthy males (N=36) directly compares formulations, but small, male-only sample limits generalizability.

Study Details

PMID:22228560
Participants:36
Impact:bioequivalent (geometric mean ratio 0.89; CI 0.81–0.98)
Trust score:3/5

CoQ10 Cmax

1 evidences

CoQ10 formulated with low-dose soybean phytosterols showed similar bioavailability to a generic CoQ10 product in healthy men.

Trust comment: Randomized cross-over in healthy males (N=36) directly compares formulations, but small, male-only sample limits generalizability.

Study Details

PMID:22228560
Participants:36
Impact:bioequivalent (geometric mean ratio 0.88; CI 0.80–0.96)
Trust score:3/5

fasting plasma CoQ10 after 4 weeks

1 evidences

CoQ10 formulated with low-dose soybean phytosterols showed similar bioavailability to a generic CoQ10 product in healthy men.

Trust comment: Randomized cross-over in healthy males (N=36) directly compares formulations, but small, male-only sample limits generalizability.

Study Details

PMID:22228560
Participants:36
Impact:~twofold increase (both formulations); no difference between groups
Trust score:3/5

plasma folic acid and vitamin B12

1 evidences

Daily fortified milk (including phytosterols) plus lifestyle counselling for 3 months improved several CVD-related markers (lower homocysteine, higher folate/B12) and tended to improve LDL:HDL; effects are from combined intervention.

Trust comment: Randomized with adequate sample but phytosterols were given within a multi-nutrient fortified milk plus lifestyle counselling, so effects cannot be attributed solely to phytosterols.

Study Details

PMID:23249766
Participants:101
Impact:significant increase in enriched milk group vs placebo and control (P<0.001)
Trust score:3/5

LDL cholesterol change (QE vs QQ)

1 evidences

Plant stanol ester intake reduced LDL-C more in subjects with ABCG5 Q604E (QE) genotype than in QQ genotype (greater LDL-C lowering when QE present).

Trust comment: Moderate-sized genotyped cohort with clear genotype-associated differential response, but single-population (Thai) and observational-genetic design limit generalizability.

Study Details

PMID:29901322
Participants:113
Impact:QE genotype: −14.17±10.67% vs QQ genotype: −3.50±10.65% (p=0.003)
Trust score:3/5

LDL oxidation resistance

1 evidences

Daily phytosterol-enriched milk (1.57 g/day) for 28 days reduced LDL-C and increased LDL resistance to oxidation and altered LDL lipid composition.

Trust comment: Randomized crossover with detailed lipidomics but small sample and short interventions limit generalizability.

Study Details

PMID:25773888
Participants:32
Impact:Increased resistance to oxidation after phytosterol-milk
Trust score:3/5

LDL glycerophospholipids (PC, PS)

1 evidences

Daily phytosterol-enriched milk (1.57 g/day) for 28 days reduced LDL-C and increased LDL resistance to oxidation and altered LDL lipid composition.

Trust comment: Randomized crossover with detailed lipidomics but small sample and short interventions limit generalizability.

Study Details

PMID:25773888
Participants:32
Impact:Reduced content in LDL glycerophospholipids (major changes in PC and PS subclasses)
Trust score:3/5

Cholesterol synthesis

1 evidences

In a 3-period crossover in healthy adults, 2 g/day plant sterols reduced cholesterol absorption but did not significantly lower LDL due to a compensatory increase in synthesis.

Trust comment: Randomized, double-blind crossover with isotope measures of absorption/synthesis (n=49); mechanistic and well-controlled.

Study Details

PMID:28112077
Participants:49
Impact:+36% (P=0.0026)
Trust score:4/5

Red cell sitosterol/campesterol:cholesterol ratio

1 evidences

In hypercholesterolemic children, sterol-ester spreads lowered plasma total and LDL cholesterol and increased red-cell plant sterol ratios when sterol esters were consumed.

Trust comment: Randomized double-blind crossover in children with small sample (n=23); design strong but limited power and pediatric-specific population.

Study Details

PMID:12756385
Participants:23
Impact:increased +40% to +52% with sterol ester (decreased 32–36% with stanol)
Trust score:3/5

Vitamin D and retinol

1 evidences

One-year sitostanol-ester margarine use lowered markers of cholesterol absorption and reduced serum beta-carotene but did not change vitamin D or retinol.

Trust comment: Long (1-year) controlled human study with adequate sample size; some imbalance in group sizes but measurements and duration are appropriate.

Study Details

PMID:10488954
Participants:151
Impact:no change
Trust score:4/5

aortic valve sterol content

1 evidences

In patients with severe aortic stenosis consuming 2 g/day plant stanols or sterols until valve replacement (~2.6 months), LDL fell but valve sterol content, structure, and inflammation were unchanged.

Trust comment: Randomized, double-blind controlled intervention but small sample and short exposure before surgery limit generalizability.

Study Details

PMID:25614126
Participants:36
Impact:no change versus control
Trust score:3/5

valve structure and inflammation

1 evidences

In patients with severe aortic stenosis consuming 2 g/day plant stanols or sterols until valve replacement (~2.6 months), LDL fell but valve sterol content, structure, and inflammation were unchanged.

Trust comment: Randomized, double-blind controlled intervention but small sample and short exposure before surgery limit generalizability.

Study Details

PMID:25614126
Participants:36
Impact:no change (collagen/elastin, macrophage and mast cell counts unchanged)
Trust score:3/5

Triacylglycerol (triglycerides)

1 evidences

Phytosterol-enriched chocolate (1.8 g/d) given for 4 weeks lowered total and LDL cholesterol without affecting HDL or triglycerides and raised markers of sterol absorption; no adverse effects.

Trust comment: Randomized double-blind placebo-controlled RCT in 70 hypercholesterolemic subjects with clear numeric lipid changes over 4 weeks.

Study Details

PMID:12425728
Participants:70
Impact:no change
Trust score:4/5

Plasma lathosterol

1 evidences

Phytosterol-enriched chocolate (1.8 g/d) given for 4 weeks lowered total and LDL cholesterol without affecting HDL or triglycerides and raised markers of sterol absorption; no adverse effects.

Trust comment: Randomized double-blind placebo-controlled RCT in 70 hypercholesterolemic subjects with clear numeric lipid changes over 4 weeks.

Study Details

PMID:12425728
Participants:70
Impact:+20.7%
Trust score:4/5

LDL aggregation susceptibility

1 evidences

Daily plant stanol ester spread (3 g/d) for 6 months reduced LDL aggregation susceptibility and altered LDL lipid composition, alongside expected LDL-C lowering.

Trust comment: Randomized 6-month intervention (n=90) with mechanistic lipidome and functional LDL assays, robust design and clear endpoints.

Study Details

PMID:32611242
Participants:90
Impact:median aggregate size decreased from 1490 nm to 620 nm (P=0.001)
Trust score:4/5

LDL binding to proteoglycans

1 evidences

Daily plant stanol ester spread (3 g/d) for 6 months reduced LDL aggregation susceptibility and altered LDL lipid composition, alongside expected LDL-C lowering.

Trust comment: Randomized 6-month intervention (n=90) with mechanistic lipidome and functional LDL assays, robust design and clear endpoints.

Study Details

PMID:32611242
Participants:90
Impact:decreased (dependent on LDL-C decrease)
Trust score:4/5

LDL lipid composition (sphingomyelins)

1 evidences

Daily plant stanol ester spread (3 g/d) for 6 months reduced LDL aggregation susceptibility and altered LDL lipid composition, alongside expected LDL-C lowering.

Trust comment: Randomized 6-month intervention (n=90) with mechanistic lipidome and functional LDL assays, robust design and clear endpoints.

Study Details

PMID:32611242
Participants:90
Impact:proportion decreased; triacylglycerols proportion increased
Trust score:4/5

TC:HDL cholesterol ratio

1 evidences

Adding 2.7 g phytosterols to daily ground beef for 4 weeks lowered total and LDL cholesterol in young men with mild hypercholesterolemia.

Trust comment: Triple-blind randomized trial with clear lipid reductions but modest sample size (n=34).

Study Details

PMID:12081816
Participants:34
Impact:−9.1% from baseline (P<0.001)
Trust score:4/5

modified Boyarsky symptom score

1 evidences

Beta-sitosterol (a phytosterol mixture) for 6 months improved urinary symptoms and flow in patients with benign prostatic hyperplasia compared with placebo.

Trust comment: Large randomized double-blind placebo-controlled multicenter trial (n=200) with clear symptomatic and objective improvements.

Study Details

PMID:7540705
Participants:200
Impact:treatment −6.7 points vs placebo −2.1 points (significant)
Trust score:4/5

International Prostate Symptom Score (IPSS)

1 evidences

Beta-sitosterol (a phytosterol mixture) for 6 months improved urinary symptoms and flow in patients with benign prostatic hyperplasia compared with placebo.

Trust comment: Large randomized double-blind placebo-controlled multicenter trial (n=200) with clear symptomatic and objective improvements.

Study Details

PMID:7540705
Participants:200
Impact:treatment −7.4 points vs placebo −2.1 points
Trust score:4/5

peak urinary flow

1 evidences

Beta-sitosterol (a phytosterol mixture) for 6 months improved urinary symptoms and flow in patients with benign prostatic hyperplasia compared with placebo.

Trust comment: Large randomized double-blind placebo-controlled multicenter trial (n=200) with clear symptomatic and objective improvements.

Study Details

PMID:7540705
Participants:200
Impact:increase from 9.9 to 15.2 mL/s (+5.3 mL/s)
Trust score:4/5

post-void residual volume

1 evidences

Beta-sitosterol (a phytosterol mixture) for 6 months improved urinary symptoms and flow in patients with benign prostatic hyperplasia compared with placebo.

Trust comment: Large randomized double-blind placebo-controlled multicenter trial (n=200) with clear symptomatic and objective improvements.

Study Details

PMID:7540705
Participants:200
Impact:decrease from 65.8 to 30.4 mL (−35.4 mL)
Trust score:4/5

abdominal circumference

1 evidences

Obese Japanese men with high LDL took rice bran ASG extract or placebo for 12 weeks; the extract group had greater reductions in LDL and some fat measures.

Trust comment: Checklist: confirm phytosterol exposure; extract top outcomes; verify participant count; evaluate quality; report changes — randomized double-blind trial with 51 participants, moderate sample and clear positive effects on LDL and non-HDL cholesterol.

Study Details

PMID:25817289
Participants:51
Impact:decrease (significant vs placebo)
Trust score:4/5

Beta-carotene (fat-soluble vitamins)

1 evidences

Mildly hypercholesterolemic Thais drank soy milk with 2 g/day plant stanols for 6 weeks and had substantial LDL and total cholesterol reductions; some fat-soluble carotenoids decreased.

Trust comment: Large (n=120), double-blind, placebo-controlled trial with clear clinically relevant LDL reductions and monitoring of vitamins; solid quality.

Study Details

PMID:22256472
Participants:120
Impact:decrease (adjusted levels reduced)
Trust score:4/5

VLDL cholesterol

1 evidences

Daily consumption of 0.45 g/day phytosterol ester in oil lowered total cholesterol and certain atherogenic lipoproteins in men with higher baseline cholesterol.

Trust comment: Randomized, double-blind, placebo-controlled parallel trial (n=60) with clinically relevant lipid endpoints; quality high for dietary RCT.

Study Details

PMID:14505991
Participants:60
Impact:-22.5% vs control
Trust score:5/5

remnant-like particle (RLP) cholesterol

1 evidences

Daily consumption of 0.45 g/day phytosterol ester in oil lowered total cholesterol and certain atherogenic lipoproteins in men with higher baseline cholesterol.

Trust comment: Randomized, double-blind, placebo-controlled parallel trial (n=60) with clinically relevant lipid endpoints; quality high for dietary RCT.

Study Details

PMID:14505991
Participants:60
Impact:-24.7% vs control
Trust score:5/5

cholesterol synthesis precursors (e.g., lathosterol)

1 evidences

In hypercholesterolemic subjects, oat-bran produced a transient total cholesterol decrease but did not change serum plant sterol proportions or cholesterol synthesis precursors substantially.

Trust comment: Randomized dietary intervention (n=36) with post-hoc sterol analyses; modest size and some outcomes transient, limiting strength.

Study Details

PMID:9306087
Participants:36
Impact:mostly unchanged
Trust score:3/5

serum POP concentration

1 evidences

In a 6‑week randomized placebo-controlled trial, increasing dietary POP doses raised serum POP rapidly (steady state <7 days) in a dose‑dependent but nonlinear way, while COP were unchanged; serum plant sterols rose modestly and cholesterol changes were minimal.

Trust comment: Randomized, double-blind, placebo-controlled design with careful measures and complete follow-up (n=60), but pilot size and post-hoc exclusions (PP2 n=52) are limitations.

Study Details

PMID:31575059
Participants:60
Impact:increased (PP2 changes from baseline: +50.2 nmol/L low, +105.9 nmol/L medium, +166.2 nmol/L high)
Trust score:4/5

serum COP concentration

1 evidences

In a 6‑week randomized placebo-controlled trial, increasing dietary POP doses raised serum POP rapidly (steady state <7 days) in a dose‑dependent but nonlinear way, while COP were unchanged; serum plant sterols rose modestly and cholesterol changes were minimal.

Trust comment: Randomized, double-blind, placebo-controlled design with careful measures and complete follow-up (n=60), but pilot size and post-hoc exclusions (PP2 n=52) are limitations.

Study Details

PMID:31575059
Participants:60
Impact:no meaningful change (e.g., change in high-dose −6.56 nmol/L)
Trust score:4/5

serum plant sterols

1 evidences

In a 6‑week randomized placebo-controlled trial, increasing dietary POP doses raised serum POP rapidly (steady state <7 days) in a dose‑dependent but nonlinear way, while COP were unchanged; serum plant sterols rose modestly and cholesterol changes were minimal.

Trust comment: Randomized, double-blind, placebo-controlled design with careful measures and complete follow-up (n=60), but pilot size and post-hoc exclusions (PP2 n=52) are limitations.

Study Details

PMID:31575059
Participants:60
Impact:increased by 7.88 μmol/L (≈+32.4%) versus control
Trust score:4/5

total cholesterol / LDL-C

1 evidences

In a 6‑week randomized placebo-controlled trial, increasing dietary POP doses raised serum POP rapidly (steady state <7 days) in a dose‑dependent but nonlinear way, while COP were unchanged; serum plant sterols rose modestly and cholesterol changes were minimal.

Trust comment: Randomized, double-blind, placebo-controlled design with careful measures and complete follow-up (n=60), but pilot size and post-hoc exclusions (PP2 n=52) are limitations.

Study Details

PMID:31575059
Participants:60
Impact:no significant change compared to control (small, non-significant reductions)
Trust score:4/5

plasma plant sterol levels

1 evidences

Plant sterol esters and stanols incorporated into various foods lowered LDL cholesterol (sterol esters ~13.6% fall; stanols ~8.3% fall) and altered plasma sterol markers without reducing plasma carotenoids.

Trust comment: Randomized single-blind crossover trials with small to moderate sample sizes (22 and 15), controlled design supports credibility.

Study Details

PMID:11781675
Participants:37
Impact:increased with sterol esters (sitosterol +35%, campesterol +51%); decreased with stanols (sitosterol −22%)
Trust score:4/5

plasma carotenoids/tocopherols

1 evidences

Plant sterol esters and stanols incorporated into various foods lowered LDL cholesterol (sterol esters ~13.6% fall; stanols ~8.3% fall) and altered plasma sterol markers without reducing plasma carotenoids.

Trust comment: Randomized single-blind crossover trials with small to moderate sample sizes (22 and 15), controlled design supports credibility.

Study Details

PMID:11781675
Participants:37
Impact:no significant change
Trust score:4/5

LDL cholesterol (beta-glucan)

1 evidences

In 40 mildly hypercholesterolemic adults, oat beta-glucan reduced LDL by 5.0% and adding 1.5 g plant stanols reduced LDL by 9.6% vs control over 4 weeks.

Trust comment: Randomized controlled 3-period crossover (n=40) with clear biomarker changes; modest size but robust within-subject design.

Study Details

PMID:17311944
Participants:40
Impact:−5.0% vs control
Trust score:4/5

LDL cholesterol (beta-glucan + 1.5 g plant stanols)

1 evidences

In 40 mildly hypercholesterolemic adults, oat beta-glucan reduced LDL by 5.0% and adding 1.5 g plant stanols reduced LDL by 9.6% vs control over 4 weeks.

Trust comment: Randomized controlled 3-period crossover (n=40) with clear biomarker changes; modest size but robust within-subject design.

Study Details

PMID:17311944
Participants:40
Impact:−9.6% vs control; −4.4% vs beta-glucan alone
Trust score:4/5

proportion achieving ≥15% reduction in serum cholesterol

1 evidences

Adding margarine with ~2 g/day plant sterols/stanols for 12 weeks helped some patients achieve ≥15% cholesterol reductions versus usual care.

Trust comment: Randomized parallel clinical outpatient study but small completed sample (n=25) limits precision and generalizability.

Study Details

PMID:15635344
Participants:25
Impact:5 of 14 in intervention vs 0 of 11 in control
Trust score:3/5

Sitosterol:campesterol ratio

1 evidences

In 29 rheumatoid arthritis patients, a strict uncooked vegan diet for 2–3 months lowered total and LDL cholesterol and changed plant sterol ratios (higher sitosterol:campesterol).

Trust comment: Randomized diet intervention in humans with clear biochemical outcomes but moderate sample size and indirect relation to supplement use.

Study Details

PMID:11242480
Participants:29
Impact:increase (1.48 vs 0.72; P<0.001)
Trust score:3/5

TBA (lipid peroxidation marker)

1 evidences

Eating bakery products enriched with sterol esters plus antioxidants for 8 weeks reduced a marker of lipid peroxidation compared with control products.

Trust comment: Randomized, double-blind design but intervention combined phytosterols with vitamins (confounding) and small sample size limits attribution solely to phytosterols.

Study Details

PMID:15556261
Participants:57
Impact:experimental group lower vs control; between-group mean difference 3.16 (P=0.044)
Trust score:3/5

Campesterol levels

1 evidences

Post-hoc analysis in FH patients found baseline plant-sterol markers did not predict LDL‑C lowering by ezetimibe/simvastatin, though the drug markedly reduced circulating campesterol and sitosterol.

Trust comment: Large post-hoc analysis of a trial (exploratory) so findings about associations are hypothesis-generating rather than definitive.

Study Details

PMID:19828909
Participants:591
Impact:-68% with ezetimibe/simvastatin
Trust score:3/5

Sitosterol levels

1 evidences

Post-hoc analysis in FH patients found baseline plant-sterol markers did not predict LDL‑C lowering by ezetimibe/simvastatin, though the drug markedly reduced circulating campesterol and sitosterol.

Trust comment: Large post-hoc analysis of a trial (exploratory) so findings about associations are hypothesis-generating rather than definitive.

Study Details

PMID:19828909
Participants:591
Impact:-62% with ezetimibe/simvastatin
Trust score:3/5

LDL cholesterol response vs baseline absorption markers

1 evidences

Post-hoc analysis in FH patients found baseline plant-sterol markers did not predict LDL‑C lowering by ezetimibe/simvastatin, though the drug markedly reduced circulating campesterol and sitosterol.

Trust comment: Large post-hoc analysis of a trial (exploratory) so findings about associations are hypothesis-generating rather than definitive.

Study Details

PMID:19828909
Participants:591
Impact:no association (no predictive relationship)
Trust score:3/5

Campesterol/TC (absorption marker)

1 evidences

Ezetimibe plus statin produced greater and more sustained LDL-C lowering than doubling statin dose, with persistent decreases in absorption markers (campesterol) over 52 weeks.

Trust comment: Randomized comparison over 52 weeks with relevant biomarker and clinical endpoints; moderate sample size.

Study Details

PMID:22892323
Participants:150
Impact:decrease (larger decrease with ezetimibe+statin)
Trust score:4/5

Lathosterol/TC (synthesis marker)

1 evidences

Ezetimibe plus statin produced greater and more sustained LDL-C lowering than doubling statin dose, with persistent decreases in absorption markers (campesterol) over 52 weeks.

Trust comment: Randomized comparison over 52 weeks with relevant biomarker and clinical endpoints; moderate sample size.

Study Details

PMID:22892323
Participants:150
Impact:increase with ezetimibe+statin
Trust score:4/5

IL-10 (anti-inflammatory)

1 evidences

Postmenopausal women who drank a beverage with 2 g/day plant sterols for 6 weeks had lower total and LDL cholesterol and changes in some sterol and cytokine markers.

Trust comment: Randomized double-blind crossover study measuring biochemical and inflammatory biomarkers in a defined cohort (n=38).

Study Details

PMID:30206618
Participants:38
Impact:increased 22.5%
Trust score:4/5

Total cholesterol:HDL ratio

1 evidences

A phytosterol-enriched rice bran oil spread consumed as part of the diet reduced total and LDL cholesterol in mildly hypercholesterolaemic adults.

Trust comment: Randomized double-blind crossover trial with adequate sample (n=80) and clear lipid outcomes.

Study Details

PMID:21320365
Participants:80
Impact:-3.4% vs standard spread
Trust score:4/5

Non‑HDL cholesterol

1 evidences

A daily stanol drink (2.0 g) lowered non‑HDL cholesterol and triglycerides in metabolic syndrome patients, including added benefit with simvastatin.

Trust comment: Randomized trial with small group sizes (n per arm 8–10); endpoints relevant but limited power due to small arms.

Study Details

PMID:19403719
Participants:36
Impact:-12.8% (stanol alone vs placebo)
Trust score:3/5

Triacylglycerol (TAG)

2 evidences

A daily stanol drink (2.0 g) lowered non‑HDL cholesterol and triglycerides in metabolic syndrome patients, including added benefit with simvastatin.

Trust comment: Randomized trial with small group sizes (n per arm 8–10); endpoints relevant but limited power due to small arms.

Study Details

PMID:19403719
Participants:36
Impact:-27.5% (stanol alone vs placebo)
Trust score:3/5

- Checklist: - Confirm human intervention(s) and select top outcomes (non-HDL/LDL, TAG, VLDL particle counts). - Extract participant numbers per study and reported numeric changes. - Assess study design and report likely mechanisms discussed. Two controlled human intervention studies (metabolic syndrome and normolipidemic groups) showed that plant stanol esters lower cholesterol and, in subjects with high baseline TAG, markedly reduce triglycerides and large VLDL particles.

Trust comment: Two double-blind placebo-controlled trials with N reported and detailed lipoprotein profiling; mechanistic interpretation partly speculative.

Study Details

PMID:19856194
Participants:130
Impact:-0.23 mmol/L (−27.5%) (metabolic syndrome subjects)
Trust score:4/5

Apo B-100/Apo A-I ratio

1 evidences

Three months of 2 g/day phytosterol plus healthy diet lowered total and LDL cholesterol and improved apolipoprotein ratio, with no change in LDL particle size.

Trust comment: Randomized parallel trial with adequate sample and clear lipid outcome reporting.

Study Details

PMID:21048770
Participants:75
Impact:-7.7%
Trust score:4/5

cardiovascular disease risk (Framingham)

1 evidences

Daily bread with 2.3 g phytosterols for 4 weeks lowered total and LDL cholesterol and reduced calculated CVD risk; HDL and TG unchanged.

Trust comment: Double-blind, placebo-controlled RCT with moderate sample and clear lipid endpoints.

Study Details

PMID:30990213
Participants:75
Impact:−12.7% relative (−1.1 absolute %)
Trust score:4/5

LDL particle number (LDL-P)

1 evidences

Daily bread with 2.3 g phytosterols for 4 weeks lowered total and LDL cholesterol and reduced calculated CVD risk; HDL and TG unchanged.

Trust comment: Double-blind, placebo-controlled RCT with moderate sample and clear lipid endpoints.

Study Details

PMID:30990213
Participants:75
Impact:decreased by 124.33 nmol/L
Trust score:4/5

ApoB/ApoA ratio

1 evidences

Incorporating phytosterols (2 g/d) in a cocoa cream for 4 weeks reduced LDL-C and improved inflammatory/oxidative biomarkers (hsCRP, oxLDL) compared with control.

Trust comment: Well-controlled, double-blind multi-arm RCT with adequate sample; phytosterols were one component of tested formulations.

Study Details

PMID:22383996
Participants:113
Impact:−7.8% to −11.8% depending on product
Trust score:4/5

postprandial lipids/glucose/insulin

1 evidences

Daily spread with ~2.2 g plant sterols for 6 weeks lowered fasting triglycerides and LDL-C in individuals with or at risk of T2DM (per-protocol analysis).

Trust comment: Large, randomized, double-blind, placebo-controlled study with predefined endpoints and appropriate analyses (per-protocol reported).

Study Details

PMID:29795368
Participants:138
Impact:no consistent effect
Trust score:5/5

non-HDL cholesterol

11 evidences

Softgel providing 1.8 g/day esterified plant sterols/stanols reduced LDL-C, non-HDL-C and total cholesterol versus placebo in adults with primary hypercholesterolemia.

Trust comment: Randomized, double-blind crossover replication study but small sample (n=30) limits precision.

Study Details

PMID:24287284
Participants:30
Impact:−4.1% (placebo-adjusted)
Trust score:4/5

Randomized double-blind crossover trial: 1.8 g/day non-esterified plant sterol/stanol tablets (6 weeks) added to TLC diet produced modest but significant reductions in atherogenic lipids.

Trust comment: Well-conducted randomized crossover trial with objective lipid endpoints, though sample size was modest.

Study Details

PMID:22087585
Participants:32
Impact:-3.6% (active vs control difference)
Trust score:4/5

Six months of plant stanol ester (~3 g/day) reduced LDL (~10%) and non-HDL cholesterol and improved arterial stiffness in small arteries (AI) and prevented progression of large-artery stiffness (CAVI) in men.

Trust comment: Well-conducted randomized, double-blind parallel trial with vascular and lipid endpoints in 92 completers showing LDL lowering and improvements in surrogate vascular measures.

Study Details

PMID:23841572
Participants:92
Impact:-10.6% vs control (p<0.001)
Trust score:4/5

In a controlled feeding crossover trial, 1.8 g/day plant sterols reduced LDL and non-HDL cholesterol in both diabetic and nondiabetic hypercholesterolemic participants.

Trust comment: Double-blind, randomized, controlled crossover feeding study with clear biochemical endpoints but small sample.

Study Details

PMID:15941886
Participants:29
Impact:decreased (P<0.05)
Trust score:4/5

3.0 g/d plant stanol esters for 4 weeks reduced total, LDL and non-HDL cholesterol in statin-treated adults with type 1 diabetes.

Trust comment: Randomized double-blind parallel human RCT with objective lipid endpoints but small sample (n=24) and short duration (4 wk).

Study Details

PMID:21514589
Participants:24
Impact:-15.3% vs baseline; -12.2% vs control
Trust score:4/5

Softgel capsules providing 1.8 g/d esterified plant sterols/stanols for 6 weeks reduced LDL, non-HDL and total cholesterol in adults with primary hypercholesterolemia.

Trust comment: Randomized, placebo-controlled crossover with objective lipid endpoints but small sample (n=28) and short treatment periods.

Study Details

PMID:22796122
Participants:28
Impact:-9.0% vs control
Trust score:4/5

Older hyperlipidemic adults consuming soy milk powder with phytosterol esters (≈2 g/day free phytosterols) for 6 months had reduced total and LDL cholesterol versus placebo.

Trust comment: Large randomized placebo-controlled trial (n=170) with clinically relevant lipid endpoints and 6-month follow-up.

Study Details

PMID:27440543
Participants:170
Impact:-12.6% (6 months vs control)
Trust score:4/5

Daily soy drink with plant sterols for 8 weeks lowered LDL, total and non-HDL cholesterol in adults with moderate hypercholesterolemia.

Trust comment: Randomized double-blind placebo-controlled trial with clear LDL primary outcome but small sample and short duration (8 weeks).

Study Details

PMID:18837970
Participants:49
Impact:-6.38% at 8 weeks (P<0.01)
Trust score:4/5

Obese Japanese men with high LDL took rice bran ASG extract or placebo for 12 weeks; the extract group had greater reductions in LDL and some fat measures.

Trust comment: Checklist: confirm phytosterol exposure; extract top outcomes; verify participant count; evaluate quality; report changes — randomized double-blind trial with 51 participants, moderate sample and clear positive effects on LDL and non-HDL cholesterol.

Study Details

PMID:25817289
Participants:51
Impact:decrease (significant vs placebo)
Trust score:4/5

Adults with mild-moderate hypercholesterolemia consumed low-fat yoghurt with ~1.9 g/day plant stanols for 4 weeks and showed modest but significant LDL and total cholesterol reductions.

Trust comment: Well-designed randomized double-blind placebo-controlled trial (n=70) with clear lipid endpoints and statistically significant LDL lowering.

Study Details

PMID:23786762
Participants:70
Impact:-6.2%
Trust score:4/5

- Checklist: - Confirm human intervention(s) and select top outcomes (non-HDL/LDL, TAG, VLDL particle counts). - Extract participant numbers per study and reported numeric changes. - Assess study design and report likely mechanisms discussed. Two controlled human intervention studies (metabolic syndrome and normolipidemic groups) showed that plant stanol esters lower cholesterol and, in subjects with high baseline TAG, markedly reduce triglycerides and large VLDL particles.

Trust comment: Two double-blind placebo-controlled trials with N reported and detailed lipoprotein profiling; mechanistic interpretation partly speculative.

Study Details

PMID:19856194
Participants:130
Impact:-0.73 mmol/L (−13.8%) (metabolic syndrome subjects)
Trust score:4/5

Total cholesterol (combination)

1 evidences

3-week double-blind placebo-controlled 2x2 factorial RCT: combination of 2 g/day phytosterols with 1.4 g/day n-3 LCPUFA produced greater lipid improvements than either alone in hyperlipidemic adults.

Trust comment: Randomized double-blind factorial design with 60 hyperlipidemic subjects showing additive benefits of phytosterols when combined with n-3 LCPUFA.

Study Details

PMID:18492838
Participants:60
Impact:-13.3% (phytosterols + n-3 LCPUFA, 3 weeks)
Trust score:4/5

LDL cholesterol (combination)

2 evidences

3-week double-blind placebo-controlled 2x2 factorial RCT: combination of 2 g/day phytosterols with 1.4 g/day n-3 LCPUFA produced greater lipid improvements than either alone in hyperlipidemic adults.

Trust comment: Randomized double-blind factorial design with 60 hyperlipidemic subjects showing additive benefits of phytosterols when combined with n-3 LCPUFA.

Study Details

PMID:18492838
Participants:60
Impact:-12.5% (phytosterols + n-3 LCPUFA, 3 weeks)
Trust score:4/5

In 4-week treatment periods, plant sterols and ezetimibe each lowered LDL-C; combination reduced LDL-C most versus placebo but offered no clear benefit over ezetimibe alone.

Trust comment: Randomized, double-blind placebo-controlled crossover for plant sterol component with open-label ezetimibe; moderate sample and clear lipid measures.

Study Details

PMID:16162943
Participants:40
Impact:-1.06 mmol/L (-25.2%)
Trust score:4/5

Triglycerides (combination)

1 evidences

3-week double-blind placebo-controlled 2x2 factorial RCT: combination of 2 g/day phytosterols with 1.4 g/day n-3 LCPUFA produced greater lipid improvements than either alone in hyperlipidemic adults.

Trust comment: Randomized double-blind factorial design with 60 hyperlipidemic subjects showing additive benefits of phytosterols when combined with n-3 LCPUFA.

Study Details

PMID:18492838
Participants:60
Impact:-25.9% (phytosterols + n-3 LCPUFA, 3 weeks)
Trust score:4/5

adiponectin

1 evidences

In hypercholesterolemic adults, plant sterol intake (with or without exercise) lowered LDL cholesterol and increased adiponectin; no changes were seen in apoA1, apoB, ghrelin, or growth hormone.

Trust comment: Randomized 8-week parallel-arm trial (n=84) directly testing plant sterols; moderate size and randomized but relatively short duration.

Study Details

PMID:18066136
Participants:84
Impact:+16% (plant sterol group)
Trust score:4/5

Serum beta-carotene

2 evidences

Plant sterol ester–enriched low-fat milk and yoghurt reduced total and LDL cholesterol (~5–10%) in modestly hypercholesterolemic adults, with no effect on HDL or triglycerides.

Trust comment: Randomized crossover trials (total completers n≈79) showing consistent cholesterol reductions in modestly hypercholesterolemic subjects; small sample sizes per study phase.

Study Details

PMID:15316827
Participants:79
Impact:-10% to -14% (in some interventions)
Trust score:4/5

One-year sitostanol-ester margarine use lowered markers of cholesterol absorption and reduced serum beta-carotene but did not change vitamin D or retinol.

Trust comment: Long (1-year) controlled human study with adequate sample size; some imbalance in group sizes but measurements and duration are appropriate.

Study Details

PMID:10488954
Participants:151
Impact:reduced (P<0.01)
Trust score:4/5

HDL cholesterol / triglycerides

1 evidences

Adults with mild–moderate hypercholesterolemia who ate low-fat foods providing 1.8 g/day phytosterols plus oat beta-glucan for 6 weeks had small but significant reductions in LDL and total cholesterol.

Trust comment: Randomized, double-blind, controlled trial with 112 participants showing modest LDL and total cholesterol lowering with phytosterol-containing foods.

Study Details

PMID:12612157
Participants:112
Impact:No significant change vs control
Trust score:4/5

Markers of cholesterol absorption (campesterol-, sitosterol-to-cholesterol ratios)

1 evidences

In HIV patients, ritonavir-boosted lopinavir increased total cholesterol and serum markers of cholesterol absorption (serum phytosterol ratios), indicating increased cholesterol absorption rather than synthesis.

Trust comment: Randomized clinical trial with objective biochemical markers showing increased serum phytosterol ratios and cholesterol with LPV/r; modest sample size.

Study Details

PMID:29683854
Participants:49
Impact:Significantly increased in LPV/r group (no change in EFV group)
Trust score:4/5

Cholesterol synthesis marker (lathosterol-to-cholesterol)

1 evidences

In HIV patients, ritonavir-boosted lopinavir increased total cholesterol and serum markers of cholesterol absorption (serum phytosterol ratios), indicating increased cholesterol absorption rather than synthesis.

Trust comment: Randomized clinical trial with objective biochemical markers showing increased serum phytosterol ratios and cholesterol with LPV/r; modest sample size.

Study Details

PMID:29683854
Participants:49
Impact:No change in either group
Trust score:4/5

Lathosterol-to-cholesterol ratio predicts response

1 evidences

Adults with low baseline lathosterol-to-cholesterol ratio (low endogenous synthesis) had larger reductions in total and LDL cholesterol when consuming 2 g/day plant sterols for 28 days, whereas high-synthesis individuals did not respond.

Trust comment: Randomized, single-blind crossover trial with biomarker-based stratification showing that baseline synthesis marker predicts response to plant sterols.

Study Details

PMID:25733626
Participants:63
Impact:Odds of response higher in low-synthesis group: OR 4.25 (TC), OR 3.36 (LDL)
Trust score:4/5

Body mass index (BMI)

1 evidences

Short randomized placebo-controlled trial: processed quinoa for 28 days reduced BMI and HbA1c and increased satiety in prediabetic patients.

Trust comment: Randomized double-blind RCT but small sample and intervention was whole processed quinoa (multiple bioactives including phytosterols), so attribution to phytosterols is uncertain.

Study Details

PMID:29130716
Participants:29
Impact:decrease (significant, p<0.05)
Trust score:3/5

glycated hemoglobin (HbA1c)

1 evidences

Short randomized placebo-controlled trial: processed quinoa for 28 days reduced BMI and HbA1c and increased satiety in prediabetic patients.

Trust comment: Randomized double-blind RCT but small sample and intervention was whole processed quinoa (multiple bioactives including phytosterols), so attribution to phytosterols is uncertain.

Study Details

PMID:29130716
Participants:29
Impact:decrease (significant, p<0.001)
Trust score:3/5

Satiation/fullness (satiety)

1 evidences

Short randomized placebo-controlled trial: processed quinoa for 28 days reduced BMI and HbA1c and increased satiety in prediabetic patients.

Trust comment: Randomized double-blind RCT but small sample and intervention was whole processed quinoa (multiple bioactives including phytosterols), so attribution to phytosterols is uncertain.

Study Details

PMID:29130716
Participants:29
Impact:increase (significant, p<0.001)
Trust score:3/5

serum campesterol

4 evidences

Esterified phytosterols (0–9 g/day) for 8 weeks were well tolerated in 84 adults; increased serum campesterol and improved total:HDL ratio at the highest dose were observed without major adverse effects.

Trust comment: Randomized, double-blind, four-arm parallel trial with adequate sample and safety assessments over 8 weeks.

Study Details

PMID:11506058
Participants:84
Impact:significant increase vs control (p<0.001)
Trust score:4/5

Over 85 weeks in 30 statin users, plant sterol margarine raised serum campesterol and lowered LDL-C; increased campesterol correlated with a small, non-significant increase in retinal venular diameter.

Trust comment: Randomized long-term trial but very small groups (N=11,8,11) limiting precision and generalizability.

Study Details

PMID:21122856
Participants:30
Impact:large increase in sterol group (reported +354.84±168.22·10^2 μmol/mmol, p<0.001)
Trust score:3/5

Short crossover feeding study showed serum campesterol and sitosterol rose proportionally to intake and both sterol/stanol mixtures similarly lowered LDL cholesterol.

Trust comment: Randomized crossover dietary intervention in 44 healthy adults with clear biochemical outcomes; moderate sample size appropriate for metabolic endpoints.

Study Details

PMID:12949359
Participants:44
Impact:+33% (high‑sterol) and +20% (low‑sterol) vs control
Trust score:4/5

In 32 adults given stearate-enriched plant sterol esters (3 g/day) for 4 weeks, LDL cholesterol fell ~11% and LDL:HDL ratio decreased ~10%.

Trust comment: Randomized, double-blind, placebo-controlled human trial with clear lipid endpoints but modest sample size and short duration.

Study Details

PMID:19535421
Participants:32
Impact:increase (significant in PS ester group)
Trust score:4/5

total:HDL cholesterol ratio (9.0 g/day)

1 evidences

Esterified phytosterols (0–9 g/day) for 8 weeks were well tolerated in 84 adults; increased serum campesterol and improved total:HDL ratio at the highest dose were observed without major adverse effects.

Trust comment: Randomized, double-blind, four-arm parallel trial with adequate sample and safety assessments over 8 weeks.

Study Details

PMID:11506058
Participants:84
Impact:-9.6% vs control (2.6%)
Trust score:4/5

triglycerides (3.0 g/day vs control)

1 evidences

Esterified phytosterols (0–9 g/day) for 8 weeks were well tolerated in 84 adults; increased serum campesterol and improved total:HDL ratio at the highest dose were observed without major adverse effects.

Trust comment: Randomized, double-blind, four-arm parallel trial with adequate sample and safety assessments over 8 weeks.

Study Details

PMID:11506058
Participants:84
Impact:-13.3% vs control (+7.8% in control)
Trust score:4/5

LDL-cholesterol (addition of plant sterols)

1 evidences

In 86 patients on lipid-lowering therapy, adding 2 g/day plant sterols for 4 weeks produced additional LDL-C reductions (~4–6.5% depending on background therapy) without further changes in absorption/synthesis markers.

Trust comment: Prospective randomized open-label with blinded endpoints and mechanistic markers; moderate sample and short treatment periods.

Study Details

PMID:26228672
Participants:86
Impact:additional reductions ~4.0–6.5% (phase II vs phase I depending on regimen)
Trust score:4/5

total cholesterol (addition of plant sterols)

1 evidences

In 86 patients on lipid-lowering therapy, adding 2 g/day plant sterols for 4 weeks produced additional LDL-C reductions (~4–6.5% depending on background therapy) without further changes in absorption/synthesis markers.

Trust comment: Prospective randomized open-label with blinded endpoints and mechanistic markers; moderate sample and short treatment periods.

Study Details

PMID:26228672
Participants:86
Impact:additional reductions ~5.0–7.7% depending on regimen
Trust score:4/5

cholesterol absorption/synthesis markers

1 evidences

In 86 patients on lipid-lowering therapy, adding 2 g/day plant sterols for 4 weeks produced additional LDL-C reductions (~4–6.5% depending on background therapy) without further changes in absorption/synthesis markers.

Trust comment: Prospective randomized open-label with blinded endpoints and mechanistic markers; moderate sample and short treatment periods.

Study Details

PMID:26228672
Participants:86
Impact:no further change after adding plant sterols
Trust score:4/5

Apolipoprotein B

10 evidences

Mildly hypercholesterolemic adults who drank orange juice fortified with 2 g/day plant sterols for 8 weeks had clinically meaningful reductions in LDL and total cholesterol.

Trust comment: Randomized, placebo‑controlled trial with adequate sample for the intervention length and clear lipid endpoints, though short duration (8 weeks).

Study Details

PMID:14764424
Participants:72
Impact:decrease (−9.5%)
Trust score:4/5

In people with metabolic syndrome and high LDL, adding a soy/phytosterol medical food plus other plant compounds to a diet improved several cholesterol measures more than diet alone.

Trust comment: Randomized trial but small subgroup (n=24) and the intervention combined multiple compounds, limiting attribution specifically to phytosterols.

Study Details

PMID:21122628
Participants:24
Impact:decreased vs control (greater improvement in PED arm, P < 0.05)
Trust score:3/5

Ezetimibe treatment reduced plasma sitosterol and campesterol concentrations in patients with sitosterolemia over 8 weeks.

Trust comment: Multicenter, randomized, placebo-controlled trial in a rare human disease (N=37) with clear biochemical endpoints; small sample but strong internal validity.

Study Details

PMID:14769702
Participants:37
Impact:decreased (reported)
Trust score:4/5

Crossover trial: fish-oil–ester plant sterols lowered triglycerides markedly and plant sterol esters lowered LDL and apoB compared with control oil.

Trust comment: Small, semi-randomized single-blind crossover with multiple interventions; physiological endpoints measured but limited sample size.

Study Details

PMID:17158440
Participants:21
Impact:Lower apoB concentrations with FO-PS and SU-PS vs olive oil
Trust score:3/5

Crossover trial showing margarines with 2 g/day plant sterols (rapeseed or tall oil) reduced LDL-C and apoB but lowered lipid-adjusted beta-carotene.

Trust comment: Double-blind randomized crossover with objective lipid measurements, moderate sample size; some nutrient effects noted.

Study Details

PMID:19748247
Participants:59
Impact:-5.3% to -6.9%
Trust score:4/5

Adding plant sterol esters to a reduced‑fat spread in a low‑fat diet lowered blood cholesterol and related lipids in adults with mild‑to‑moderate high cholesterol.

Trust comment: Randomized double‑blind parallel trial with clear lipid endpoints and per‑protocol effect sizes reported.

Study Details

PMID:11451715
Participants:224
Impact:−6.2% (1.1 g/d), −8.4% (2.2 g/d)
Trust score:4/5

Different doses of plant stanol esters produced a dose‑dependent reduction in total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Single‑blind, within‑subject dose‑response in 22 participants; small sample but consistent dose effects.

Study Details

PMID:10736328
Participants:22
Impact:−8.7% (0.8 g/d)
Trust score:3/5

Low‑fat margarine and milk providing 2.3 g/day plant sterols reduced total and LDL cholesterol in mildly hypercholesterolemic adults.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover with 46 completers; clinically relevant endpoints and clear percent changes reported.

Study Details

PMID:17719702
Participants:46
Impact:-4.6%
Trust score:4/5

Daily intake of a plant sterol–enriched spread for 4 weeks lowered total and LDL cholesterol and apolipoprotein B without affecting HDL.

Trust comment: Randomized double-blind placebo-controlled crossover (n=42) showing consistent lipid-lowering effects with plant sterol intake.

Study Details

PMID:12003257
Participants:42
Impact:-8% (−0.08 g/L)
Trust score:5/5

Daily ingestion of 2 g plant stanols lowered LDL-C (~9–10%) and ApoB (~5–9%) in Japanese subjects; response was not influenced by ApoE phenotype.

Trust comment: Randomized, placebo-controlled trial with >100 subjects and clear lipid endpoints; good quality for dietary intervention.

Study Details

PMID:12093429
Participants:105
Impact:-5.4% (E3), -8.9% (E4)
Trust score:4/5

Other cardiometabolic analytes (HDL, TG, glucose, insulin, hsCRP)

1 evidences

In statin-intolerant/unwilling adults, snack products containing a mix of cholesterol-lowering bioactives (including phytosterols) twice daily reduced LDL and total cholesterol over four weeks compared with control snacks.

Trust comment: Well-designed double-blind randomized crossover trial with clear numeric effects, though the product contained multiple active ingredients including phytosterols.

Study Details

PMID:35079806
Participants:54
Impact:no significant difference vs control
Trust score:5/5

Antioxidant status / oxidative stress markers

1 evidences

In statin-treated patients, adding plant sterol or stanol (2.5 g/day) for 16 weeks lowered LDL cholesterol but did not change antioxidant status, oxidative stress markers, endothelial or low-grade inflammation markers.

Trust comment: Double-blind randomized placebo-controlled design in statin-treated patients with clear LDL effect but modest sample size.

Study Details

PMID:17487211
Participants:41
Impact:no change
Trust score:4/5

Markers of endothelial dysfunction and low-grade inflammation (sICAM/sVCAM/CRP/MCP-1)

1 evidences

In statin-treated patients, adding plant sterol or stanol (2.5 g/day) for 16 weeks lowered LDL cholesterol but did not change antioxidant status, oxidative stress markers, endothelial or low-grade inflammation markers.

Trust comment: Double-blind randomized placebo-controlled design in statin-treated patients with clear LDL effect but modest sample size.

Study Details

PMID:17487211
Participants:41
Impact:no change
Trust score:4/5

campesterol (cholesterol absorption marker)

1 evidences

During active weight loss phytosterol (campesterol) levels rose and synthesis marker (lanosterol) fell, with rebounds over long-term follow-up and an overall increase from baseline at 24 months.

Trust comment: Well-characterized randomized dietary trial with moderate sample size and repeated measures, providing reliable metabolic data.

Study Details

PMID:21940598
Participants:90
Impact:+16.8% (first 6 mo); rebound -6.2% (next 18 mo); overall higher than baseline at 24 mo (P<0.001)
Trust score:4/5

lanosterol (cholesterol synthesis marker)

1 evidences

During active weight loss phytosterol (campesterol) levels rose and synthesis marker (lanosterol) fell, with rebounds over long-term follow-up and an overall increase from baseline at 24 months.

Trust comment: Well-characterized randomized dietary trial with moderate sample size and repeated measures, providing reliable metabolic data.

Study Details

PMID:21940598
Participants:90
Impact:-16.5% (first 6 mo); rebound +43.7% (next 18 mo); overall higher than baseline at 24 mo (P=0.016)
Trust score:4/5

home systolic blood pressure

1 evidences

A spread containing milk peptides plus 2 g plant sterols daily modestly reduced home systolic blood pressure and lowered total and LDL cholesterol versus placebo.

Trust comment: Randomized double-blind design and moderate size, but effect attribution to plant sterols is confounded by co-administered bioactive peptides.

Study Details

PMID:22398753
Participants:104
Impact:-4.1 mmHg vs -0.5 mmHg (active vs placebo, p=0.007)
Trust score:3/5

lipid-adjusted alpha- and beta-carotene

1 evidences

Daily intake of 1.6 g plant sterol esters in a spread for 1 year lowered total and LDL cholesterol modestly and was safe with no adverse hormone or clinical-chemical effects.

Trust comment: Large (n=185), randomized double-blind placebo-controlled 1-year trial with comprehensive safety measures.

Study Details

PMID:12771969
Participants:185
Impact:reduced by 15–25% after 1 year
Trust score:5/5

total cholesterol (combination group)

1 evidences

In an 8-week randomized trial plant sterols (with or without exercise) reduced cholesterol absorption and, when combined with exercise, produced favorable lipid changes including lower LDL.

Trust comment: Randomized, parallel-arm human trial (n=84) with direct measures of cholesterol kinetics; moderate duration (8 weeks).

Study Details

PMID:17196519
Participants:84
Impact:−7.7%
Trust score:4/5

LDL cholesterol (combination group)

1 evidences

In an 8-week randomized trial plant sterols (with or without exercise) reduced cholesterol absorption and, when combined with exercise, produced favorable lipid changes including lower LDL.

Trust comment: Randomized, parallel-arm human trial (n=84) with direct measures of cholesterol kinetics; moderate duration (8 weeks).

Study Details

PMID:17196519
Participants:84
Impact:−0.30 mmol/L
Trust score:4/5

lathosterol:cholesterol ratio (marker of synthesis)

1 evidences

Daily intake of ~2 g phytosterols delivered in milk for 4 weeks lowered LDL cholesterol by about 7–8% in hypercholesterolaemic subjects.

Trust comment: Randomized placebo-controlled crossover in hypercholesterolemic subjects (n=43) with direct lipid and sterol biomarker measures.

Study Details

PMID:22018049
Participants:43
Impact:increased by 11–25%
Trust score:4/5

sitosterol:cholesterol and campesterol:cholesterol ratios (absorption markers)

1 evidences

Daily intake of ~2 g phytosterols delivered in milk for 4 weeks lowered LDL cholesterol by about 7–8% in hypercholesterolaemic subjects.

Trust comment: Randomized placebo-controlled crossover in hypercholesterolemic subjects (n=43) with direct lipid and sterol biomarker measures.

Study Details

PMID:22018049
Participants:43
Impact:increased by 70–120%
Trust score:4/5

inflammatory markers (e.g., hs-CRP, myeloperoxidase)

1 evidences

In medicated secondary prevention patients, a low-fat diet that included 2 g/day phytosterols (TLCD) decreased LDL and oxidized LDL compared with a Mediterranean diet, but diets differed in multiple components.

Trust comment: Randomized dietary comparison in medicated patients (n=40) but phytosterols were part of a broader dietary intervention, limiting attribution to phytosterols alone.

Study Details

PMID:21890081
Participants:40
Impact:no significant change
Trust score:3/5

plasma beta-carotene / tocopherols

1 evidences

People eating bakery products delivering 3.2 g/day sterol esters for 8 weeks had lower total and LDL cholesterol without reductions in measured antioxidants.

Trust comment: Randomized double-blind placebo-controlled trial with direct sterol-enriched food intervention and clear biochemical outcomes, moderate sample size.

Study Details

PMID:14519792
Participants:57
Impact:no significant change
Trust score:4/5

Cholesterol synthesis / fecal neutral sterols

1 evidences

Phytostanol-ester enriched foods reduced LDL-C ~10–13% and lowered cholesterol absorption similarly in high and low absorbers.

Trust comment: Post-hoc analysis of randomized, double-blind controlled trials in humans with direct biochemical measures; modest sample but appropriate design.

Study Details

PMID:38301283
Participants:41
Impact:increase (statistically significant), greater in high absorbers
Trust score:4/5

antioxidant activity (MDA)

1 evidences

In 100 postmenopausal women given Diascorea (source of phytosterols) for 12 months, transient antioxidant improvement at 6 months and changes in blood cell indices (decreased WBC at 6 months; increased hematocrit and MCV at 12 months) were observed, while lipid changes were not significant.

Trust comment: Randomized, double‑blind placebo‑controlled 12‑month study with moderate sample size but relatively low phytosterol dose; outcomes reported clearly.

Study Details

PMID:29206136
Participants:100
Impact:transient improvement at 6 months (P<0.001), not sustained at 12 months
Trust score:4/5

WBC count

1 evidences

In 100 postmenopausal women given Diascorea (source of phytosterols) for 12 months, transient antioxidant improvement at 6 months and changes in blood cell indices (decreased WBC at 6 months; increased hematocrit and MCV at 12 months) were observed, while lipid changes were not significant.

Trust comment: Randomized, double‑blind placebo‑controlled 12‑month study with moderate sample size but relatively low phytosterol dose; outcomes reported clearly.

Study Details

PMID:29206136
Participants:100
Impact:decreased at 6 months (significant)
Trust score:4/5

hematocrit

1 evidences

In 100 postmenopausal women given Diascorea (source of phytosterols) for 12 months, transient antioxidant improvement at 6 months and changes in blood cell indices (decreased WBC at 6 months; increased hematocrit and MCV at 12 months) were observed, while lipid changes were not significant.

Trust comment: Randomized, double‑blind placebo‑controlled 12‑month study with moderate sample size but relatively low phytosterol dose; outcomes reported clearly.

Study Details

PMID:29206136
Participants:100
Impact:increased after 12 months (significant)
Trust score:4/5

MCV

1 evidences

In 100 postmenopausal women given Diascorea (source of phytosterols) for 12 months, transient antioxidant improvement at 6 months and changes in blood cell indices (decreased WBC at 6 months; increased hematocrit and MCV at 12 months) were observed, while lipid changes were not significant.

Trust comment: Randomized, double‑blind placebo‑controlled 12‑month study with moderate sample size but relatively low phytosterol dose; outcomes reported clearly.

Study Details

PMID:29206136
Participants:100
Impact:increased after 12 months (significant)
Trust score:4/5

plasma lipids

1 evidences

In 100 postmenopausal women given Diascorea (source of phytosterols) for 12 months, transient antioxidant improvement at 6 months and changes in blood cell indices (decreased WBC at 6 months; increased hematocrit and MCV at 12 months) were observed, while lipid changes were not significant.

Trust comment: Randomized, double‑blind placebo‑controlled 12‑month study with moderate sample size but relatively low phytosterol dose; outcomes reported clearly.

Study Details

PMID:29206136
Participants:100
Impact:no significant change
Trust score:4/5

IPSS (prostatic symptom score)

1 evidences

In 177 men with BPH, 6 months of 130 mg/day beta‑sitosterol improved urinary symptoms (IPSS) and quality of life, increased peak urine flow, and reduced post-void residual volume versus placebo.

Trust comment: Large multicenter, double‑blind, placebo‑controlled trial with clinically meaningful objective and subjective endpoints.

Study Details

PMID:9313662
Participants:177
Impact:improvement: mean difference vs placebo -5.4 points
Trust score:5/5

peak urinary flow (Qmax)

1 evidences

In 177 men with BPH, 6 months of 130 mg/day beta‑sitosterol improved urinary symptoms (IPSS) and quality of life, increased peak urine flow, and reduced post-void residual volume versus placebo.

Trust comment: Large multicenter, double‑blind, placebo‑controlled trial with clinically meaningful objective and subjective endpoints.

Study Details

PMID:9313662
Participants:177
Impact:+4.5 mL/s (adjusted increase vs placebo)
Trust score:5/5

post-void residual volume (PVR)

2 evidences

In 177 men with BPH, 6 months of 130 mg/day beta‑sitosterol improved urinary symptoms (IPSS) and quality of life, increased peak urine flow, and reduced post-void residual volume versus placebo.

Trust comment: Large multicenter, double‑blind, placebo‑controlled trial with clinically meaningful objective and subjective endpoints.

Study Details

PMID:9313662
Participants:177
Impact:-33.5 mL (adjusted decrease vs placebo)
Trust score:5/5

In 36 BPH patients, a 3-month Difaprost® (contains β-sitosterol among other agents) course showed non-significant improvements in urine residual and flow and reduced some histologic edema.

Trust comment: Randomized clinical trial in humans but small sample, combination product (multiple active agents) and mostly non-significant clinical changes.

Study Details

PMID:24988203
Participants:36
Impact:-20.9 mL (46.1 → 25.2 mL; P=0.10, not significant)
Trust score:3/5

plasma oxyphytosterols (overall)

1 evidences

Healthy adults consuming plant sterol or stanol margarine had lower LDL cholesterol; sterols did not raise oxyphytosterols, while stanols reduced some oxyphytosterol metabolites.

Trust comment: Randomized double-blind cross-over trial in 43 healthy adults with appropriate analytical methods; moderate sample size.

Study Details

PMID:23375753
Participants:43
Impact:no change with plant sterol intake
Trust score:4/5

7β-OH-campesterol and 7-keto-campesterol

1 evidences

Healthy adults consuming plant sterol or stanol margarine had lower LDL cholesterol; sterols did not raise oxyphytosterols, while stanols reduced some oxyphytosterol metabolites.

Trust comment: Randomized double-blind cross-over trial in 43 healthy adults with appropriate analytical methods; moderate sample size.

Study Details

PMID:23375753
Participants:43
Impact:reduced (~14–15%) with plant stanol intake
Trust score:4/5

Ex vivo T-cell cytokine production (IFN-γ, IL-2, IL-4, IL-13, IL-10, IL-17)

1 evidences

In healthy volunteers, recommended (2.5 g/d) or high (9.0 g/d) plant stanol intake did not change ex vivo T-cell cytokine production; the high dose did lower total and LDL cholesterol.

Trust comment: Randomized controlled parent trials and validated assays, but immunologic analyses were done on small subgroups limiting power for immune endpoints.

Study Details

PMID:39506323
Participants:39
Impact:no change (no between-group differences)
Trust score:4/5

Th1/Th2 index

1 evidences

In healthy volunteers, recommended (2.5 g/d) or high (9.0 g/d) plant stanol intake did not change ex vivo T-cell cytokine production; the high dose did lower total and LDL cholesterol.

Trust comment: Randomized controlled parent trials and validated assays, but immunologic analyses were done on small subgroups limiting power for immune endpoints.

Study Details

PMID:39506323
Participants:39
Impact:no change (mean diff 0.03; 95% CI −0.23 to 0.29; P=0.807)
Trust score:4/5

Total cholesterol (9.0 g/d)

1 evidences

In healthy volunteers, recommended (2.5 g/d) or high (9.0 g/d) plant stanol intake did not change ex vivo T-cell cytokine production; the high dose did lower total and LDL cholesterol.

Trust comment: Randomized controlled parent trials and validated assays, but immunologic analyses were done on small subgroups limiting power for immune endpoints.

Study Details

PMID:39506323
Participants:39
Impact:−0.82 mmol/L (P<0.001)
Trust score:4/5

LDL cholesterol (9.0 g/d)

1 evidences

In healthy volunteers, recommended (2.5 g/d) or high (9.0 g/d) plant stanol intake did not change ex vivo T-cell cytokine production; the high dose did lower total and LDL cholesterol.

Trust comment: Randomized controlled parent trials and validated assays, but immunologic analyses were done on small subgroups limiting power for immune endpoints.

Study Details

PMID:39506323
Participants:39
Impact:−0.77 mmol/L (P<0.001)
Trust score:4/5

Beta-carotene bioavailability

1 evidences

In a randomized crossover trial in men, both free and esterified plant sterols reduced cholesterol absorption (~60%) and lowered beta-carotene (~50%) and alpha-tocopherol (~20%) bioavailability; esters had larger reductions than free sterols.

Trust comment: Double-blind randomized crossover with metabolic measures and standardized diet, though small sample of men only.

Study Details

PMID:15213045
Participants:26
Impact:≈−50% (greater reduction with sterol esters vs free sterols)
Trust score:4/5

Alpha-tocopherol bioavailability

1 evidences

In a randomized crossover trial in men, both free and esterified plant sterols reduced cholesterol absorption (~60%) and lowered beta-carotene (~50%) and alpha-tocopherol (~20%) bioavailability; esters had larger reductions than free sterols.

Trust comment: Double-blind randomized crossover with metabolic measures and standardized diet, though small sample of men only.

Study Details

PMID:15213045
Participants:26
Impact:≈−20% (greater reduction with sterol esters; difference at margin for AUC P=0.054)
Trust score:4/5

Endothelin-1 (ET-1)

1 evidences

Adults with moderate high cholesterol drank phytosterol-enriched soy milk and had lower LDL and endothelin-1, with some lipid improvements in higher‑LDL participants.

Trust comment: Randomized, double‑blind, placebo‑controlled human trial but small sample (n=38) and short treatment periods limit generalizability.

Study Details

PMID:32455866
Participants:38
Impact:decrease (overall significant; −12% in LDL responders, −8% in LDL non-responders)
Trust score:4/5

Beta-sitosterol (serum)

1 evidences

Postmenopausal women randomized to a plant‑based dietary program had higher circulating phytosterols (especially beta‑sitosterol) and larger total cholesterol reductions than controls.

Trust comment: Randomized dietary intervention with moderate sample size and meaningful biochemical outcomes, but non‑blinded and behavioral intervention may introduce bias.

Study Details

PMID:14652381
Participants:104
Impact:increase (absolute and percent change significant vs control; P=0.0017)
Trust score:3/5

Total phytosterols (serum)

1 evidences

Postmenopausal women randomized to a plant‑based dietary program had higher circulating phytosterols (especially beta‑sitosterol) and larger total cholesterol reductions than controls.

Trust comment: Randomized dietary intervention with moderate sample size and meaningful biochemical outcomes, but non‑blinded and behavioral intervention may introduce bias.

Study Details

PMID:14652381
Participants:104
Impact:absolute increase (greater in intervention vs control)
Trust score:3/5

Maternal sitostanol (serum)

1 evidences

Small randomized study in pregnant women found maternal biochemical markers changed in expected directions with stanol intake and no major clinical safety signals for mothers or infants, though infant carotene merits monitoring.

Trust comment: Randomized safety study but very small (n=21) and underpowered for rare outcomes; biochemical markers consistent with mechanism.

Study Details

PMID:19017423
Participants:21
Impact:increase (with consumption ≈1.1–1.4 g/day)
Trust score:3/5

Maternal cholesterol synthesis markers (lathosterol)

1 evidences

Small randomized study in pregnant women found maternal biochemical markers changed in expected directions with stanol intake and no major clinical safety signals for mothers or infants, though infant carotene merits monitoring.

Trust comment: Randomized safety study but very small (n=21) and underpowered for rare outcomes; biochemical markers consistent with mechanism.

Study Details

PMID:19017423
Participants:21
Impact:increase (markers of synthesis increased)
Trust score:3/5

Infant cholesterol‑adjusted serum beta‑carotene

1 evidences

Small randomized study in pregnant women found maternal biochemical markers changed in expected directions with stanol intake and no major clinical safety signals for mothers or infants, though infant carotene merits monitoring.

Trust comment: Randomized safety study but very small (n=21) and underpowered for rare outcomes; biochemical markers consistent with mechanism.

Study Details

PMID:19017423
Participants:21
Impact:decrease at 1 month (lowered when adjusted for cholesterol)
Trust score:3/5

serum carotenoids

1 evidences

Plant sterol esters (1.1–2.2 g/d) lowered total and LDL cholesterol in ApoE2 and ApoE3 carriers but not in ApoE4 carriers, and reduced certain serum carotenoids in some genotypes.

Trust comment: Large randomized controlled study with genotype stratification and objective measures, but responses varied by genotype limiting generalizability.

Study Details

PMID:19056656
Participants:217
Impact:Reductions in several carotenoids (beta-carotene, lycopene, alpha-carotene, cryptoxanthin, zeaxanthin, lutein) in some ApoE genotypes (P<0.05 vs control)
Trust score:4/5

Total cholesterol (TC), HDL-C, triglycerides, insulin, blood pressure

1 evidences

1.5 g/d phytosterol capsules added to NCEP Step 2 diet for 8 weeks did not reduce LDL-C or other measured metabolic parameters in children/adolescents with dyslipidemia.

Trust comment: Randomized double-blind crossover pediatric RCT with good adherence to capsules but limited by short duration and low diet adherence as noted by authors.

Study Details

PMID:33290971
Participants:31
Impact:No significant differences vs control (all p>0.05)
Trust score:4/5

Serum sitosterol

2 evidences

Fifteen-week consumption of foods enriched with increasing doses of nonesterified plant sterols raised serum sitosterol but caused no serious adverse effects; a modest fall in serum alpha‑tocopherol was observed (dependent on LDL changes).

Trust comment: Double-blind, placebo-controlled feeding trial with 71 completers and clear biochemical endpoints; good internal validity.

Study Details

PMID:18270526
Participants:71
Impact:absolute +2.51 mg/L (from 2.84 to 5.35 mg/L) vs placebo
Trust score:4/5

Short crossover feeding study showed serum campesterol and sitosterol rose proportionally to intake and both sterol/stanol mixtures similarly lowered LDL cholesterol.

Trust comment: Randomized crossover dietary intervention in 44 healthy adults with clear biochemical outcomes; moderate sample size appropriate for metabolic endpoints.

Study Details

PMID:12949359
Participants:44
Impact:+19% (high‑sterol) and +11% (low‑sterol) vs control
Trust score:4/5

Serum alpha‑tocopherol

1 evidences

Fifteen-week consumption of foods enriched with increasing doses of nonesterified plant sterols raised serum sitosterol but caused no serious adverse effects; a modest fall in serum alpha‑tocopherol was observed (dependent on LDL changes).

Trust comment: Double-blind, placebo-controlled feeding trial with 71 completers and clear biochemical endpoints; good internal validity.

Study Details

PMID:18270526
Participants:71
Impact:-10% (between‑group difference disappeared after LDL adjustment)
Trust score:4/5

sitosterol concentration

1 evidences

Ezetimibe treatment reduced plasma sitosterol and campesterol concentrations in patients with sitosterolemia over 8 weeks.

Trust comment: Multicenter, randomized, placebo-controlled trial in a rare human disease (N=37) with clear biochemical endpoints; small sample but strong internal validity.

Study Details

PMID:14769702
Participants:37
Impact:-21% vs +4% placebo (between-group P<0.001)
Trust score:4/5

campesterol concentration

1 evidences

Ezetimibe treatment reduced plasma sitosterol and campesterol concentrations in patients with sitosterolemia over 8 weeks.

Trust comment: Multicenter, randomized, placebo-controlled trial in a rare human disease (N=37) with clear biochemical endpoints; small sample but strong internal validity.

Study Details

PMID:14769702
Participants:37
Impact:-24% vs +3% placebo (between-group P<0.001)
Trust score:4/5

nocturia severity

1 evidences

A 3-month combination product including B‑sitosterol improved nocturia, daytime frequency, and overall BPH symptom scores versus placebo.

Trust comment: Randomized, double-blind trial with good completer N but multi‑ingredient product prevents isolating B‑sitosterol-specific effects.

Study Details

PMID:12092634
Participants:127
Impact:decreased (significant, p<0.001)
Trust score:3/5

daytime urinary frequency

1 evidences

A 3-month combination product including B‑sitosterol improved nocturia, daytime frequency, and overall BPH symptom scores versus placebo.

Trust comment: Randomized, double-blind trial with good completer N but multi‑ingredient product prevents isolating B‑sitosterol-specific effects.

Study Details

PMID:12092634
Participants:127
Impact:decreased (significant, p<0.04)
Trust score:3/5

AUA Symptom Index (overall)

1 evidences

A 3-month combination product including B‑sitosterol improved nocturia, daytime frequency, and overall BPH symptom scores versus placebo.

Trust comment: Randomized, double-blind trial with good completer N but multi‑ingredient product prevents isolating B‑sitosterol-specific effects.

Study Details

PMID:12092634
Participants:127
Impact:improved (significant, p<0.014)
Trust score:3/5

flow-mediated dilatation

1 evidences

~2 g/day plant stanol or sterol esters for 10 weeks lowered LDL cholesterol modestly but did not change flow-mediated dilation; sterol esters slightly reduced brachial artery diameter.

Trust comment: Randomized double-blind crossover with parallel controls and adequate sample size; direct phytosterol intervention supports moderate-high trust.

Study Details

PMID:16386259
Participants:76
Impact:no change
Trust score:4/5

brachial artery diameter

1 evidences

~2 g/day plant stanol or sterol esters for 10 weeks lowered LDL cholesterol modestly but did not change flow-mediated dilation; sterol esters slightly reduced brachial artery diameter.

Trust comment: Randomized double-blind crossover with parallel controls and adequate sample size; direct phytosterol intervention supports moderate-high trust.

Study Details

PMID:16386259
Participants:76
Impact:reduced by 2.2% during STEEST vs STAEST (p=0.012)
Trust score:4/5

Safety/clinical labs

1 evidences

Short trials testing doses of plant sterol in dressings found LDL lowering at higher doses and no safety problems at very high dose.

Trust comment: Randomized human trial with modest sample size and short duration; subgroup effects reported which reduce robustness.

Study Details

PMID:18075220
Participants:89
Impact:No clinically relevant adverse changes at 2400 mg/day (reported as safe)
Trust score:3/5

Cholesterol synthesis (lathosterol)

1 evidences

An 8.8 g/day plant stanol ester intervention for 10 weeks lowered total and LDL cholesterol and decreased absorption markers while increasing synthesis markers; serum stanol levels rose modestly and normalized after washout.

Trust comment: Randomized double-blind parallel study (n=49) with clear biochemical endpoints; moderate sample size and 10-week duration.

Study Details

PMID:19774436
Participants:49
Impact:+30%
Trust score:4/5

Cholesterol absorption markers

1 evidences

An 8.8 g/day plant stanol ester intervention for 10 weeks lowered total and LDL cholesterol and decreased absorption markers while increasing synthesis markers; serum stanol levels rose modestly and normalized after washout.

Trust comment: Randomized double-blind parallel study (n=49) with clear biochemical endpoints; moderate sample size and 10-week duration.

Study Details

PMID:19774436
Participants:49
Impact:-up to 62%
Trust score:4/5

interleukin-6 (IL-6)

1 evidences

In hyperlipidemic adults, combined n‑3 PUFA and plant sterols for 3 weeks lowered inflammation markers and overall cardiovascular risk.

Trust comment: Randomized double-blind 2x2 factorial RCT in humans; well-designed but short duration and combined treatment makes isolating plant sterol effect less certain.

Study Details

PMID:18977480
Participants:60
Impact:-10.7% (P=0.009)
Trust score:4/5

Overall cardiovascular risk

1 evidences

In hyperlipidemic adults, combined n‑3 PUFA and plant sterols for 3 weeks lowered inflammation markers and overall cardiovascular risk.

Trust comment: Randomized double-blind 2x2 factorial RCT in humans; well-designed but short duration and combined treatment makes isolating plant sterol effect less certain.

Study Details

PMID:18977480
Participants:60
Impact:-22.6% (P=0.006)
Trust score:4/5

Lp(a)

1 evidences

6-week crossover in hypercholesterolemic adults: sterol-enriched yogurt and vine-ripened tomato sauce (high adherence) both reduced LDL-C; tomato sauce effects similar magnitude to sterol product in adherent subjects.

Trust comment: Crossover trial with 91 completers and dietetic supervision; partially unblinded due to different products but reasonable methodology.

Study Details

PMID:33407609
Participants:91
Impact:Tomato sauce (high adherence) reduced Lp(a) from 34.5 ±43 to 29.4 ±36 nmol/L (P=0.019)
Trust score:4/5

triacylglycerol

4 evidences

Adding plant sterol esters to a reduced‑fat spread in a low‑fat diet lowered blood cholesterol and related lipids in adults with mild‑to‑moderate high cholesterol.

Trust comment: Randomized double‑blind parallel trial with clear lipid endpoints and per‑protocol effect sizes reported.

Study Details

PMID:11451715
Participants:224
Impact:−10.4% (2.2 g/d, high‑sterol group)
Trust score:4/5

Four weeks of yoghurt with 2 g plant stanol ester in obese women lowered total and LDL cholesterol but did not change HDL or triglycerides.

Trust comment: Single-blind, placebo-controlled with reasonable sample size (n=90) though short duration (4 weeks).

Study Details

PMID:25060157
Participants:90
Impact:no change
Trust score:4/5

Consuming 2.5 g plant stanols daily (either once or divided) lowered LDL cholesterol; HDL and triglycerides were unchanged.

Trust comment: Randomized, double‑blind, placebo‑controlled crossover (39 subjects) with clear LDL effect and appropriate control periods.

Study Details

PMID:11002377
Participants:39
Impact:No change
Trust score:4/5

- Checklist: - Confirm randomized crossover single-blind human trial and primary outcomes (lipids). - Extract participant count and main lipid changes. - Note study limitations (single morning dose administration). In adults with mild-to-moderate hypercholesterolemia, single morning doses of several plant sterol preparations for 29 days did not lower total or LDL cholesterol but were associated with an approximate 8% increase in HDL.

Trust comment: Randomized crossover single-blind trial with small sample and unconventional single-dose-with-breakfast design reducing generalizability.

Study Details

PMID:16549466
Participants:30
Impact:no significant change
Trust score:3/5

arterial plant sterols

1 evidences

Short preoperative consumption of stanol or sterol spreads lowered blood cholesterol in statin‑treated patients; stanols tended to reduce arterial plant sterols.

Trust comment: Randomized double‑blind study in a small, specialized perioperative statin‑treated population; limited generalizability.

Study Details

PMID:20096545
Participants:22
Impact:plant stanol tended to reduce carotid artery plant sterols; sitostanol unchanged in arterial tissue
Trust score:3/5

Total cholesterol (soyabean sterol spread)

1 evidences

In a 9-week double-blind crossover (n=76), a spread enriched with 0.8 g/day free soybean-derived plant sterols lowered total and LDL cholesterol modestly; another sterol source did not lower cholesterol.

Trust comment: Balanced double-blind crossover RCT (n=76) showing modest, statistically significant LDL lowering with low-dose free plant sterols.

Study Details

PMID:10655976
Participants:76
Impact:−3.8% (≈−0.19 mmol/L) vs control
Trust score:4/5

LDL cholesterol (soyabean sterol spread)

1 evidences

In a 9-week double-blind crossover (n=76), a spread enriched with 0.8 g/day free soybean-derived plant sterols lowered total and LDL cholesterol modestly; another sterol source did not lower cholesterol.

Trust comment: Balanced double-blind crossover RCT (n=76) showing modest, statistically significant LDL lowering with low-dose free plant sterols.

Study Details

PMID:10655976
Participants:76
Impact:−6.0% (≈−0.19 mmol/L) vs control
Trust score:4/5

Apolipoprotein B (high vs low baseline campesterol)

1 evidences

In 61 hypercholesterolemic outpatients on low-dose pravastatin, PS dissolved in DAG oil (≈0.5 g/d PS) produced additional cholesterol-lowering vs controls and greater apoB reductions in patients with higher baseline campesterol.

Trust comment: Randomized small outpatient trial (n=61) showing added benefit of phytosterol oil with low-dose statin; limited sample size and subgroup findings.

Study Details

PMID:17964767
Participants:61
Impact:−13.2 mg/dL vs −3.1 mg/dL (greater reduction in high campesterol subgroup)
Trust score:3/5

Lipoprotein(a)

1 evidences

In 61 hypercholesterolemic outpatients on low-dose pravastatin, PS dissolved in DAG oil (≈0.5 g/d PS) produced additional cholesterol-lowering vs controls and greater apoB reductions in patients with higher baseline campesterol.

Trust comment: Randomized small outpatient trial (n=61) showing added benefit of phytosterol oil with low-dose statin; limited sample size and subgroup findings.

Study Details

PMID:17964767
Participants:61
Impact:−5.9 mg/dL (from baseline)
Trust score:3/5

LDL cholesterol (PS/DAG)

1 evidences

In 61 hypercholesterolemic outpatients on low-dose pravastatin, PS dissolved in DAG oil (≈0.5 g/d PS) produced additional cholesterol-lowering vs controls and greater apoB reductions in patients with higher baseline campesterol.

Trust comment: Randomized small outpatient trial (n=61) showing added benefit of phytosterol oil with low-dose statin; limited sample size and subgroup findings.

Study Details

PMID:17964767
Participants:61
Impact:significant reduction from baseline (exact % not reported in text excerpt)
Trust score:3/5

Apo-B concentration

1 evidences

In 53 people with metabolic syndrome, plant-sterol–enriched margarine (recommended serving) lowered Apo-B and the Apo-B/Apo-A1 ratio versus other fats, with no change in inflammatory markers.

Trust comment: Randomized single-blind trial in humans with a small sample (n=53); single-blind design and limited size reduce confidence.

Study Details

PMID:20648041
Participants:53
Impact:-10.4% (P=0.043)
Trust score:3/5

Apo-B/Apo-A1 ratio

1 evidences

In 53 people with metabolic syndrome, plant-sterol–enriched margarine (recommended serving) lowered Apo-B and the Apo-B/Apo-A1 ratio versus other fats, with no change in inflammatory markers.

Trust comment: Randomized single-blind trial in humans with a small sample (n=53); single-blind design and limited size reduce confidence.

Study Details

PMID:20648041
Participants:53
Impact:-11.1% (P=0.034)
Trust score:3/5

inflammatory markers (CRP, IL-6, CD40L, E-selectin)

1 evidences

In 53 people with metabolic syndrome, plant-sterol–enriched margarine (recommended serving) lowered Apo-B and the Apo-B/Apo-A1 ratio versus other fats, with no change in inflammatory markers.

Trust comment: Randomized single-blind trial in humans with a small sample (n=53); single-blind design and limited size reduce confidence.

Study Details

PMID:20648041
Participants:53
Impact:no significant change
Trust score:3/5

serum lutein/zeaxanthin concentration

1 evidences

Eating margarine with plant sterols/stanols for 18 months lowered blood carotenoid levels but did not change macular pigment.

Trust comment: Double-blind placebo-controlled human trial but modest sample size and three-arm split limits power for some outcomes.

Study Details

PMID:18986598
Participants:47
Impact:decrease (significant; differences between groups, P=0.001)
Trust score:4/5

macular pigment optical density (MPOD)

1 evidences

Eating margarine with plant sterols/stanols for 18 months lowered blood carotenoid levels but did not change macular pigment.

Trust comment: Double-blind placebo-controlled human trial but modest sample size and three-arm split limits power for some outcomes.

Study Details

PMID:18986598
Participants:47
Impact:no change
Trust score:4/5

LDL particle distribution / size (LDL pattern B prevalence)

1 evidences

One month of psyllium plus plant sterols lowered LDL cholesterol, shifted LDL toward larger particles, and increased LDL receptor abundance.

Trust comment: Randomized double-blind crossover with mechanistic measures; sample moderate (n=33) but results biologically plausible.

Study Details

PMID:17449576
Participants:33
Impact:increased peak LDL size (+0.2 nm) and decreased pattern B prevalence (27% to 18%)
Trust score:4/5

LDL receptor abundance (mononuclear cells, mRNA)

1 evidences

One month of psyllium plus plant sterols lowered LDL cholesterol, shifted LDL toward larger particles, and increased LDL receptor abundance.

Trust comment: Randomized double-blind crossover with mechanistic measures; sample moderate (n=33) but results biologically plausible.

Study Details

PMID:17449576
Participants:33
Impact:+26% abundance
Trust score:4/5

e-selectin

1 evidences

In 58 hypercholesterolemic volunteers, margarines with 2 g/day plant sterols lowered LDL (~8–9%) and rapeseed-derived sterols improved some vascular markers (E-selectin, tPAI-1).

Trust comment: Double-blind randomized crossover with 58 completers and relevant biomarker endpoints; well-designed though short treatment periods.

Study Details

PMID:25553599
Participants:58
Impact:decrease (rapeseed-sterol vs control; P=0.012)
Trust score:4/5

tPAI-1 (total)

1 evidences

In 58 hypercholesterolemic volunteers, margarines with 2 g/day plant sterols lowered LDL (~8–9%) and rapeseed-derived sterols improved some vascular markers (E-selectin, tPAI-1).

Trust comment: Double-blind randomized crossover with 58 completers and relevant biomarker endpoints; well-designed though short treatment periods.

Study Details

PMID:25553599
Participants:58
Impact:decrease (rapeseed-sterol vs tall-sterol; P=0.008)
Trust score:4/5

serum campesterol (marker of sterol absorption)

1 evidences

Low-fat margarines containing plant stanol esters added to a low-fat diet reduced total and LDL cholesterol in hypercholesterolemic adults.

Trust comment: Randomized, double-blind parallel trial in humans with clear lipid endpoints and statistically significant results; moderate sample size.

Study Details

PMID:10075323
Participants:55
Impact:WSEM: -34.5%; VOSEM: -41.3%
Trust score:4/5

hsCRP (inflammation marker)

1 evidences

Omega-3 plant sterol esters reduced triglycerides and modestly lowered diastolic BP and hsCRP but did not change LDL in mixed hyperlipidemic patients.

Trust comment: Randomized, double-blind trial with meaningful findings but substantial dropouts (24/91) and mixed intervention limits certainty.

Study Details

PMID:20617456
Participants:67
Impact:-7.8% (−0.6 mg/L)
Trust score:3/5

Beta-carotene (LDL-standardized)

1 evidences

Daily low-fat yoghurt containing plant stanol esters lowered LDL cholesterol within 1 week; some fat-soluble antioxidants changed.

Trust comment: Randomized parallel study with clear lipid endpoints but modest sample size and short duration (4 weeks).

Study Details

PMID:11755939
Participants:60
Impact:-14.4%
Trust score:4/5

Hospitalization time

1 evidences

Randomized trial (MEBO versus standard therapy using povidone iodine plus bepanthenol) in ~211 hospitalized patients with partial-thickness burns: MEBO reduced hospital stay, time to 50% wound healing (superficial burns), and pain/analgesic use compared with the povidone-iodine standard.

Trust comment: Randomized trial with meaningful clinical and economic endpoints; single-center and partly unblinded which may bias some outcomes.

Study Details

PMID:22132709
Participants:211
Impact:reduced by ~1 day overall (~20.6% reduction)
Trust score:4/5

Time to 50% wound healing (superficial burns)

1 evidences

Randomized trial (MEBO versus standard therapy using povidone iodine plus bepanthenol) in ~211 hospitalized patients with partial-thickness burns: MEBO reduced hospital stay, time to 50% wound healing (superficial burns), and pain/analgesic use compared with the povidone-iodine standard.

Trust comment: Randomized trial with meaningful clinical and economic endpoints; single-center and partly unblinded which may bias some outcomes.

Study Details

PMID:22132709
Participants:211
Impact:-2.0 days (~-19.1%)
Trust score:4/5

pain

1 evidences

Randomized trial (MEBO versus standard therapy using povidone iodine plus bepanthenol) in ~211 hospitalized patients with partial-thickness burns: MEBO reduced hospital stay, time to 50% wound healing (superficial burns), and pain/analgesic use compared with the povidone-iodine standard.

Trust comment: Randomized trial with meaningful clinical and economic endpoints; single-center and partly unblinded which may bias some outcomes.

Study Details

PMID:22132709
Participants:211
Impact:lower median pain scores after ~2–3 days (statistically significant)
Trust score:4/5

HDL and triglycerides

1 evidences

In a 3‑month randomized study, adding phytosterols to canned tuna produced a significantly larger reduction in total and LDL cholesterol than tuna alone.

Trust comment: Large randomized single‑blind dietary intervention with consistent lipid outcomes, though exact effect sizes versus control not reported in the summary text.

Study Details

PMID:17594856
Participants:400
Impact:no significant change
Trust score:4/5

cryptoxanthin (carotenoid)

1 evidences

Adding 2 g/day plant sterol–enriched milk to a healthy diet reduced total and LDL cholesterol without worsening overall antioxidant status, though one carotenoid (cryptoxanthin) fell.

Trust comment: Randomized parallel trial with defined interventions and measured biochemical outcomes; moderate quality.

Study Details

PMID:19889524
Participants:40
Impact:-29%
Trust score:4/5

oxidized LDL (OxLDL)

1 evidences

Incorporating phytosterols (2 g/d) in a cocoa cream for 4 weeks reduced LDL-C and improved inflammatory/oxidative biomarkers (hsCRP, oxLDL) compared with control.

Trust comment: Well-controlled, double-blind multi-arm RCT with adequate sample; phytosterols were one component of tested formulations.

Study Details

PMID:22383996
Participants:113
Impact:LMN: −6% (−4.0 U/L)
Trust score:4/5

LDL/HDL ratio

4 evidences

Daily fortified milk (including phytosterols) plus lifestyle counselling for 3 months improved several CVD-related markers (lower homocysteine, higher folate/B12) and tended to improve LDL:HDL; effects are from combined intervention.

Trust comment: Randomized with adequate sample but phytosterols were given within a multi-nutrient fortified milk plus lifestyle counselling, so effects cannot be attributed solely to phytosterols.

Study Details

PMID:23249766
Participants:101
Impact:favourable change in enriched milk group (trend vs placebo/control, P=0.066)
Trust score:3/5

Placebo-controlled double-blind trial: rapidly disintegrating stanol-lecithin tablets (1.26 g stanols/day) for 6 weeks lowered LDL compared with placebo; slowly disintegrating capsules had no effect.

Trust comment: Randomized double-blind placebo-controlled trial with 52 subjects and significant LDL reductions for rapidly disintegrating tablet formulation.

Study Details

PMID:15969949
Participants:52
Impact:-11.5% (tablets vs placebo, 6 weeks)
Trust score:4/5

In high cardiovascular risk subjects, increasing phytosterols from natural foods (nuts) raised phytosterol intake and was associated with lower LDL cholesterol and improved LDL/HDL ratio.

Trust comment: Substudy within a larger randomized dietary trial (PREDIMED) with 106 participants; reasonable design though observational components limit causality.

Study Details

PMID:19412676
Participants:106
Impact:-11.5% vs low-fat
Trust score:4/5

Study tested plant sterol–fortified spreads on cholesterol; measured 25-OH-vitamin D and found no change, but the intervention was not vitamin D supplementation.

Trust comment: Randomized, double‑blind, placebo‑controlled design with 100 subjects and dose‑response data; credible and informative.

Study Details

PMID:10334658
Participants:100
Impact:Decrease 0.13–0.16 units (≈6.5–7.9%)
Trust score:4/5

HDL cholesterol and triglycerides

2 evidences

Crossover RCT: yogurt with 4 g/day plant stanol esters reduced total and LDL cholesterol over 4 weeks versus placebo without safety concerns.

Trust comment: Randomized double-blind placebo-controlled crossover with good compliance and clear lipid endpoints, though short duration (4 weeks per period).

Study Details

PMID:25099071
Participants:40
Impact:no significant change
Trust score:4/5

In 112 non-hypercholesterolemic adults, consumption of stanol-ester products (vegetable or wood based) lowered LDL by ~13–15% with no change in HDL or triglycerides.

Trust comment: Controlled intervention with >100 participants; results robust for LDL lowering though population was non-hypercholesterolemic.

Study Details

PMID:10580176
Participants:112
Impact:no significant change
Trust score:4/5

Total/LDL cholesterol

1 evidences

One-year consumption of plant sterol or stanol esters in hypercholesterolemic adults reduced serum cholesterol; genetic polymorphisms did not predict cholesterol-lowering response, though some genotypes related to vascular measures.

Trust comment: 1-year human intervention with moderate sample (n=282) reporting cholesterol lowering, but abstract lacks numeric effect sizes and focuses on genotype interactions.

Study Details

PMID:19019257
Participants:282
Impact:decreased (no percent reported)
Trust score:3/5

Vascular endothelial function (flow-mediated dilation)

1 evidences

One-year consumption of plant sterol or stanol esters in hypercholesterolemic adults reduced serum cholesterol; genetic polymorphisms did not predict cholesterol-lowering response, though some genotypes related to vascular measures.

Trust comment: 1-year human intervention with moderate sample (n=282) reporting cholesterol lowering, but abstract lacks numeric effect sizes and focuses on genotype interactions.

Study Details

PMID:19019257
Participants:282
Impact:no treatment-related change; baseline differences by ABCG8 genotype
Trust score:3/5

intima-media thickness (IMT)

1 evidences

One-year consumption of plant sterol or stanol esters in hypercholesterolemic adults reduced serum cholesterol; genetic polymorphisms did not predict cholesterol-lowering response, though some genotypes related to vascular measures.

Trust comment: 1-year human intervention with moderate sample (n=282) reporting cholesterol lowering, but abstract lacks numeric effect sizes and focuses on genotype interactions.

Study Details

PMID:19019257
Participants:282
Impact:IMT progression greater in subjects with ABCG8 400K allele (not treatment-specific)
Trust score:3/5

HDL cholesterol / HbA1c

1 evidences

In type 2 diabetic patients, a phytosterol-enriched spread reduced total and LDL cholesterol (peak ~5–7% at 4 weeks) with effects attenuating over 12 weeks; small HDL increase and transient HbA1c reduction observed.

Trust comment: Randomized, double-blind controlled trial in 85 T2D patients with repeated measures showing modest lipid improvements but attenuation over time.

Study Details

PMID:12638032
Participants:85
Impact:HDL increased at 8–12 weeks vs placebo; small transient HbA1c reduction at 4 weeks
Trust score:4/5

Plasma sitosterol & campesterol

1 evidences

In healthy and mildly hypercholesterolemic adults, margarines enriched with plant sterols or sitostanol esters reduced total and LDL cholesterol by about 8–13% over ~3.5-week treatment periods without lowering HDL.

Trust comment: Randomized, double-blind Latin-square design with 95 completers demonstrating consistent LDL/TC lowering by sterol-enriched margarines.

Study Details

PMID:9630383
Participants:95
Impact:Increased with soybean oil sterol margarine; decreased with sitostanol-ester margarine
Trust score:4/5

triglycerides (TG)

2 evidences

Individuals with metabolic syndrome took phytosterol nanoparticles or placebo for 6 months; phytosterols reduced triglycerides and waist circumference and lowered metabolic syndrome severity, while vitamin D levels fell similarly in both groups (seasonal effect).

Trust comment: Well-powered, multi-site randomized double-blind placebo-controlled trial with objective metabolic endpoints and 202 completers; results are internally consistent.

Study Details

PMID:32785036
Participants:202
Impact:−15.17% (phytosterol vs placebo at 24 weeks; adjusted difference −27.49 mg/dL, p=0.004)
Trust score:5/5

Randomized double-blind trial (4 weeks) showed a spread with 2.0 g/day plant sterols + 1.0 g/day EPA+DHA lowered triglycerides and LDL‑cholesterol versus placebo.

Trust comment: Large randomized double-blind placebo-controlled trial with high compliance and objective lipid outcomes; additive fish‑oil component means some effects may be due to combined treatment.

Study Details

PMID:29725824
Participants:259
Impact:−10.6% versus placebo (p<0.001)
Trust score:5/5

Waist circumference (WC)

1 evidences

Individuals with metabolic syndrome took phytosterol nanoparticles or placebo for 6 months; phytosterols reduced triglycerides and waist circumference and lowered metabolic syndrome severity, while vitamin D levels fell similarly in both groups (seasonal effect).

Trust comment: Well-powered, multi-site randomized double-blind placebo-controlled trial with objective metabolic endpoints and 202 completers; results are internally consistent.

Study Details

PMID:32785036
Participants:202
Impact:−3.76 cm (adjusted phytosterol vs placebo; p=0.001; median reduction ≈4 cm)
Trust score:5/5

Metabolic syndrome severity (MetS‑Z)

1 evidences

Individuals with metabolic syndrome took phytosterol nanoparticles or placebo for 6 months; phytosterols reduced triglycerides and waist circumference and lowered metabolic syndrome severity, while vitamin D levels fell similarly in both groups (seasonal effect).

Trust comment: Well-powered, multi-site randomized double-blind placebo-controlled trial with objective metabolic endpoints and 202 completers; results are internally consistent.

Study Details

PMID:32785036
Participants:202
Impact:decrease by 0.199 in phytosterol group vs increase 0.009 in placebo (p=0.0024)
Trust score:5/5

Cholesterol absorption efficiency

2 evidences

Phytostanol-ester enriched foods reduced LDL-C ~10–13% and lowered cholesterol absorption similarly in high and low absorbers.

Trust comment: Post-hoc analysis of randomized, double-blind controlled trials in humans with direct biochemical measures; modest sample but appropriate design.

Study Details

PMID:38301283
Participants:41
Impact:reduction ~41% (low absorbers) and ~47% (high absorbers)
Trust score:4/5

Heterozygotes and controls took ~1.6 g/day plant sterols for 4 weeks; LDL fell in both groups while plant sterol levels rose and absorption decreased with compensatory synthesis increase.

Trust comment: Randomized, double-blind, crossover placebo-controlled study with direct kinetic measures; small sample but rigorous methods.

Study Details

PMID:22378727
Participants:25
Impact:decrease (~22% in HET; ~17% in controls)
Trust score:4/5

Markers of intestinal cholesterol absorption (campesterol, sitosterol, cholestanol)

1 evidences

Randomized placebo-controlled crossover trial: 17-day spirulina or wakame (4.8 g/day) did not change markers of cholesterol absorption/synthesis or serum lipids, glucose, or blood pressure in healthy non‑hypercholesterolemic adults.

Trust comment: Well-controlled double‑blind crossover design with good compliance; short duration and non‑hypercholesterolemic population limit detection of effects.

Study Details

PMID:31388739
Participants:35
Impact:no change versus placebo
Trust score:4/5

Serum lipids (TC, LDL‑C, HDL‑C, TG)

1 evidences

Randomized placebo-controlled crossover trial: 17-day spirulina or wakame (4.8 g/day) did not change markers of cholesterol absorption/synthesis or serum lipids, glucose, or blood pressure in healthy non‑hypercholesterolemic adults.

Trust comment: Well-controlled double‑blind crossover design with good compliance; short duration and non‑hypercholesterolemic population limit detection of effects.

Study Details

PMID:31388739
Participants:35
Impact:no change versus placebo
Trust score:4/5

retinal venular diameter

1 evidences

Over 85 weeks in 30 statin users, plant sterol margarine raised serum campesterol and lowered LDL-C; increased campesterol correlated with a small, non-significant increase in retinal venular diameter.

Trust comment: Randomized long-term trial but very small groups (N=11,8,11) limiting precision and generalizability.

Study Details

PMID:21122856
Participants:30
Impact:mean change +2.3 μm in sterol group (not statistically significant) and correlated with campesterol (r=0.39, p=0.033)
Trust score:3/5

triglycerides and HDL-cholesterol

1 evidences

In 157 adults with hypercholesterolemia consuming milk with 1.58 g/day phytosterol ester for 2 months, total cholesterol and LDL-C were significantly reduced vs normal milk and non-dairy groups.

Trust comment: Community RCT with moderate size and 2-month follow-up; results support LDL/TC lowering but some outcomes lacked detailed magnitudes in report.

Study Details

PMID:29903120
Participants:157
Impact:TG increased; HDL unchanged (no significant difference vs controls)
Trust score:3/5

LDL:HDL cholesterol ratio

2 evidences

In postmenopausal women, different stanol-enriched margarines and butters (≈2.4–3.2 g/d stanols) reduced LDL cholesterol and LDL/HDL ratio and modestly increased HDL, while some carotenoids decreased.

Trust comment: Controlled double-blind crossover study with direct measured lipid effects but small sample of 23 postmenopausal women limits generalizability.

Study Details

PMID:10337856
Participants:23
Impact:-11–15% (P < 0.05)
Trust score:4/5

In 32 adults given stearate-enriched plant sterol esters (3 g/day) for 4 weeks, LDL cholesterol fell ~11% and LDL:HDL ratio decreased ~10%.

Trust comment: Randomized, double-blind, placebo-controlled human trial with clear lipid endpoints but modest sample size and short duration.

Study Details

PMID:19535421
Participants:32
Impact:-10% decrease
Trust score:4/5

plasma sitosterol

2 evidences

In patients with primary hypercholesterolemia, ezetimibe reduced phytosterol (absorption) markers, statins reduced synthesis markers, and combined therapy lowered both classes of non-cholesterol sterols.

Trust comment: Large post-hoc analysis of randomized trials with robust statistical significance, but exploratory (post-hoc) nature limits causal certainty.

Study Details

PMID:18053317
Participants:975
Impact:decreased (p<0.001)
Trust score:4/5

Consuming 3 g/day plant sterol spreads raised plasma sitosterol and campesterol within 4 weeks and levels then remained stable through 12 weeks.

Trust comment: Large randomized, placebo‑controlled parallel trial (n=240), registered and with precise biochemical measures; high reliability.

Study Details

PMID:26806045
Participants:240
Impact:+69% (95% CI: 58–82) within 4 weeks
Trust score:5/5

plasma campesterol

2 evidences

In patients with primary hypercholesterolemia, ezetimibe reduced phytosterol (absorption) markers, statins reduced synthesis markers, and combined therapy lowered both classes of non-cholesterol sterols.

Trust comment: Large post-hoc analysis of randomized trials with robust statistical significance, but exploratory (post-hoc) nature limits causal certainty.

Study Details

PMID:18053317
Participants:975
Impact:decreased (p<0.001)
Trust score:4/5

Consuming 3 g/day plant sterol spreads raised plasma sitosterol and campesterol within 4 weeks and levels then remained stable through 12 weeks.

Trust comment: Large randomized, placebo‑controlled parallel trial (n=240), registered and with precise biochemical measures; high reliability.

Study Details

PMID:26806045
Participants:240
Impact:+28% (95% CI: 19–39) within 4 weeks
Trust score:5/5

desmosterol (cholesterol synthesis marker)

1 evidences

In patients with primary hypercholesterolemia, ezetimibe reduced phytosterol (absorption) markers, statins reduced synthesis markers, and combined therapy lowered both classes of non-cholesterol sterols.

Trust comment: Large post-hoc analysis of randomized trials with robust statistical significance, but exploratory (post-hoc) nature limits causal certainty.

Study Details

PMID:18053317
Participants:975
Impact:decreased (p<0.001)
Trust score:4/5

total cholesterol to HDL-C ratio

1 evidences

In healthy middle-aged adults, daily plant stanol ester margarine reduced total cholesterol, LDL and triglycerides over 4 weeks of supplementation.

Trust comment: Randomized, double-blind but small sample and short duration limit generalizability.

Study Details

PMID:16546486
Participants:26
Impact:decreased (P<0.05)
Trust score:3/5

total cholesterol (sterol-enriched milk)

1 evidences

Different food matrices delivering 1.6 g/day phytosterols variably lowered LDL and total cholesterol, with milk showing the largest reductions.

Trust comment: Randomized crossover single-blind trial with clear within-subject comparisons, though modest sample size.

Study Details

PMID:14985690
Participants:58
Impact:-8.7%
Trust score:4/5

LDL cholesterol (sterol-enriched milk)

1 evidences

Different food matrices delivering 1.6 g/day phytosterols variably lowered LDL and total cholesterol, with milk showing the largest reductions.

Trust comment: Randomized crossover single-blind trial with clear within-subject comparisons, though modest sample size.

Study Details

PMID:14985690
Participants:58
Impact:-15.9%
Trust score:4/5

LDL cholesterol (sterol-enriched yoghurt)

1 evidences

Different food matrices delivering 1.6 g/day phytosterols variably lowered LDL and total cholesterol, with milk showing the largest reductions.

Trust comment: Randomized crossover single-blind trial with clear within-subject comparisons, though modest sample size.

Study Details

PMID:14985690
Participants:58
Impact:-8.6%
Trust score:4/5

LDL cholesterol (sterol-enriched bread)

1 evidences

Different food matrices delivering 1.6 g/day phytosterols variably lowered LDL and total cholesterol, with milk showing the largest reductions.

Trust comment: Randomized crossover single-blind trial with clear within-subject comparisons, though modest sample size.

Study Details

PMID:14985690
Participants:58
Impact:-6.5%
Trust score:4/5

LDL cholesterol (sterol-enriched cereal)

1 evidences

Different food matrices delivering 1.6 g/day phytosterols variably lowered LDL and total cholesterol, with milk showing the largest reductions.

Trust comment: Randomized crossover single-blind trial with clear within-subject comparisons, though modest sample size.

Study Details

PMID:14985690
Participants:58
Impact:-5.4%
Trust score:4/5

LDL cholesterol (nondiabetic)

1 evidences

In a controlled feeding crossover trial, 1.8 g/day plant sterols reduced LDL and non-HDL cholesterol in both diabetic and nondiabetic hypercholesterolemic participants.

Trust comment: Double-blind, randomized, controlled crossover feeding study with clear biochemical endpoints but small sample.

Study Details

PMID:15941886
Participants:29
Impact:-15.1%
Trust score:4/5

LDL cholesterol (diabetic)

1 evidences

In a controlled feeding crossover trial, 1.8 g/day plant sterols reduced LDL and non-HDL cholesterol in both diabetic and nondiabetic hypercholesterolemic participants.

Trust comment: Double-blind, randomized, controlled crossover feeding study with clear biochemical endpoints but small sample.

Study Details

PMID:15941886
Participants:29
Impact:-26.8%
Trust score:4/5

fecal plant sterol excretion

1 evidences

Postmenopausal women drinking a beverage with 2 g/day plant sterols showed changed fecal sterol patterns and reduced microbial conversion of some sterols.

Trust comment: Well-controlled randomized double-blind crossover trial with 40 participants and direct biochemical measurements.

Study Details

PMID:30243503
Participants:40
Impact:increased (significant)
Trust score:4/5

cholesterol microbial conversion (%)

1 evidences

Postmenopausal women drinking a beverage with 2 g/day plant sterols showed changed fecal sterol patterns and reduced microbial conversion of some sterols.

Trust comment: Well-controlled randomized double-blind crossover trial with 40 participants and direct biochemical measurements.

Study Details

PMID:30243503
Participants:40
Impact:decreased (11–50% decrease in 16 women)
Trust score:4/5

sitosterol conversion (%)

1 evidences

Postmenopausal women drinking a beverage with 2 g/day plant sterols showed changed fecal sterol patterns and reduced microbial conversion of some sterols.

Trust comment: Well-controlled randomized double-blind crossover trial with 40 participants and direct biochemical measurements.

Study Details

PMID:30243503
Participants:40
Impact:decreased (15–61% decrease in 24 women)
Trust score:4/5

plasma beta-carotene

2 evidences

Hypercholesterolemic men consuming 21 g/day of a plant sterol-enriched spread had modest reductions in total and LDL cholesterol; beta-carotene fell unless dietary fruit/veg advice was followed.

Trust comment: Randomized double-blind crossover study with 48 participants and relevant biochemical endpoints, though short intervention periods.

Study Details

PMID:15546434
Participants:48
Impact:decreased (significant before lipid standardisation; not significant after standardisation)
Trust score:4/5

In hypercholesterolemic subjects, spreads with plant sterol/stanol esters lowered LDL (~7.7–9.5%) while dietary advice to add a high-carotenoid serving maintained plasma carotenoids.

Trust comment: Double-blind randomized crossover (n=46) with clear biochemical endpoints; adequate design though sample modest.

Study Details

PMID:11756063
Participants:46
Impact:+13% with dietary advice (control); maintained (no significant reduction) when sterol/stanol spreads consumed with advice
Trust score:4/5

ApoB-100

2 evidences

A once-daily 2.5 g phytosterol drink reduced LDL-C, total cholesterol and ApoB-100 versus placebo; larger reductions seen in those with higher Mediterranean-diet adherence.

Trust comment: Double-blind, randomized, placebo-controlled crossover in humans with good completion and compliance, though short treatment periods (3 weeks) limit long-term conclusions.

Study Details

PMID:37960208
Participants:49
Impact:decrease (statistically significant)
Trust score:4/5

Phytosterol-enriched milk (2 g/day) reduced cholesterol measures in non-MetS patients (LDL ~-10.5%) but produced little or no benefit in MetS patients.

Trust comment: Randomized parallel trial but small subgroup sizes and limited power; findings plausible but sample-limited.

Study Details

PMID:21489663
Participants:48
Impact:-6.2% (non-MetS); no meaningful change (MetS)
Trust score:3/5

Plasma plant sterols (campesterol, β-sitosterol)

2 evidences

26-week open-label follow-up: daily plant sterol–enriched spread produced sustained LDL and total cholesterol reductions and increased circulating plant sterol markers.

Trust comment: Open-label follow-up with moderate sample (57) and some parents on statins; sustained effects but less controlled than blinded RCTs.

Study Details

PMID:15199384
Participants:57
Impact:campesterol (adjusted) +92–96%; β-sitosterol (adjusted) +39–48% (varies children/parents)
Trust score:3/5

Large multicentre randomized trial: a portfolio diet including phytosterols reduced LDL-C substantially (~13%) and did not alter fat‑soluble vitamin levels after cholesterol adjustment.

Trust comment: Large randomized multicentre trial (n=351) with appropriate analyses and clinically relevant endpoints; some drop-outs and <100% adherence noted.

Study Details

PMID:25326876
Participants:351
Impact:significant increases in campesterol and β-sitosterol concentrations and their cholesterol-adjusted ratios
Trust score:5/5

Fat-soluble vitamins (α/γ‑tocopherol, retinol, carotenoids)

1 evidences

Large multicentre randomized trial: a portfolio diet including phytosterols reduced LDL-C substantially (~13%) and did not alter fat‑soluble vitamin levels after cholesterol adjustment.

Trust comment: Large randomized multicentre trial (n=351) with appropriate analyses and clinically relevant endpoints; some drop-outs and <100% adherence noted.

Study Details

PMID:25326876
Participants:351
Impact:no meaningful change after adjustment for cholesterol (no adverse effect)
Trust score:5/5

carotenoid levels (beta-carotene, lycopene)

1 evidences

In ~84 mildly hypercholesterolemic patients, 2 g/day phytosterol-enriched low‑fat milk for 3 months reduced total and LDL cholesterol similarly across diets (LDL reductions ~7–9.6%) without consistent harm to carotenoids when combined with a healthy diet.

Trust comment: Randomized 3‑month parallel trial with clear lipid endpoints and moderate sample size; diet stratification well described.

Study Details

PMID:20456813
Participants:84
Impact:variable: no change in healthy diet+PS; decreases in free diet+PS (β-carotene -21.0%, lycopene -22.8%)
Trust score:4/5

total/HDL cholesterol ratio

3 evidences

In 67 hypercholesterolemic adults, consuming cocoa snack bars with 1.5 g phytosterols twice daily for 6 weeks lowered total cholesterol (~4.7%) and LDL (~6%) and the total/HDL ratio, with a small reduction in lipid-adjusted beta‑carotene.

Trust comment: Randomized, double‑blind parallel trial with moderate sample size and clear lipid outcomes; short duration (6 weeks).

Study Details

PMID:17081832
Participants:67
Impact:-7.4% (6 weeks)
Trust score:4/5

In 21 overweight people with high cholesterol, olive-oil-esterified plant sterols reduced LDL and (for the olive-oil formulation) decreased LDL susceptibility to peroxidation.

Trust comment: Randomized crossover in humans with 28-day periods but small sample and limited magnitude reporting.

Study Details

PMID:17559697
Participants:21
Impact:decrease (P=0.0142) with PS treatments
Trust score:3/5

A daily stanol drink (2.0 g) lowered non‑HDL cholesterol and triglycerides in metabolic syndrome patients, including added benefit with simvastatin.

Trust comment: Randomized trial with small group sizes (n per arm 8–10); endpoints relevant but limited power due to small arms.

Study Details

PMID:19403719
Participants:36
Impact:Significant decrease (no % provided)
Trust score:3/5

lipid-adjusted beta-carotene

2 evidences

In 67 hypercholesterolemic adults, consuming cocoa snack bars with 1.5 g phytosterols twice daily for 6 weeks lowered total cholesterol (~4.7%) and LDL (~6%) and the total/HDL ratio, with a small reduction in lipid-adjusted beta‑carotene.

Trust comment: Randomized, double‑blind parallel trial with moderate sample size and clear lipid outcomes; short duration (6 weeks).

Study Details

PMID:17081832
Participants:67
Impact:decreased (significant)
Trust score:4/5

Crossover trial showing margarines with 2 g/day plant sterols (rapeseed or tall oil) reduced LDL-C and apoB but lowered lipid-adjusted beta-carotene.

Trust comment: Double-blind randomized crossover with objective lipid measurements, moderate sample size; some nutrient effects noted.

Study Details

PMID:19748247
Participants:59
Impact:decrease (P<0.017)
Trust score:4/5

blood pressure / systemic vascular resistance / cardiac index

1 evidences

In metabolic syndrome subjects, fermented milk containing lactotripeptides plus 2 g/d plant sterol esters produced a borderline lipid-lowering effect but did not change blood pressure or haemodynamic measures versus placebo.

Trust comment: Randomized double-blind trial (n=104) but combined active ingredients (lactotripeptides + plant sterols) and borderline significance limit attribution specifically to phytosterols.

Study Details

PMID:26168857
Participants:104
Impact:no significant change vs placebo
Trust score:3/5

Total serum cholesterol

2 evidences

In renal transplant recipients with hypercholesterolaemia, stanol-containing functional foods reduced serum cholesterol more than control over 3 months (between-group difference significant).

Trust comment: Randomized parallel-group clinical study with a reasonable sample size but limited detail on magnitude and blinding reported in abstract.

Study Details

PMID:19200277
Participants:84
Impact:decrease in intervention vs control (between-group P=0.0196)
Trust score:3/5

Consuming low-fat dairy products with ~2 g/day plant sterols for 6 weeks reduced total and LDL cholesterol without lowering fat-soluble vitamin levels.

Trust comment: Large, multi-site double-blind randomized trial with clear, statistically significant lipid changes and safety measures reported.

Study Details

PMID:16404415
Participants:164
Impact:-6.5% (sterol group)
Trust score:5/5

Serum triglycerides (EPA+DHA dose-response)

1 evidences

In a large randomized double-blind trial, spreads containing plant sterols (2.5 g/d) plus graded low doses of EPA+DHA dose-dependently lowered triglycerides (9.3–16.2%) and plant-sterol-containing groups lowered LDL-C (11.5–14.7%) versus control.

Trust comment: Large randomized double-blind placebo-controlled trial with dose-response results and good compliance metrics (erythrocyte EPA/DHA).

Study Details

PMID:25122648
Participants:314
Impact:−9.3% to −16.2% versus control (dose-dependent)
Trust score:5/5

LDL cholesterol (plant sterol groups)

1 evidences

In a large randomized double-blind trial, spreads containing plant sterols (2.5 g/d) plus graded low doses of EPA+DHA dose-dependently lowered triglycerides (9.3–16.2%) and plant-sterol-containing groups lowered LDL-C (11.5–14.7%) versus control.

Trust comment: Large randomized double-blind placebo-controlled trial with dose-response results and good compliance metrics (erythrocyte EPA/DHA).

Study Details

PMID:25122648
Participants:314
Impact:−11.5% to −14.7% versus control
Trust score:5/5

LDL cholesterol (LDL-C)

6 evidences

3.0 g/d plant stanol esters for 4 weeks reduced total, LDL and non-HDL cholesterol in statin-treated adults with type 1 diabetes.

Trust comment: Randomized double-blind parallel human RCT with objective lipid endpoints but small sample (n=24) and short duration (4 wk).

Study Details

PMID:21514589
Participants:24
Impact:-16.4% vs baseline; -14.8% vs control
Trust score:4/5

1.6 g/d plant sterols in low-fat yogurt consumed as a snack modestly lowered total cholesterol and tended to lower LDL while increasing cholesterol synthesis; fat-soluble vitamins unchanged.

Trust comment: Randomized within-subject trial with controlled diets and objective biochemical outcomes, moderate sample (n=26); some effects borderline significant.

Study Details

PMID:18845709
Participants:26
Impact:Endpoint LDL-C tended lower (control 3.51 → snack 3.33 mmol/L; ≈-5.4%; p=0.06)
Trust score:4/5

Plant sterol esters (1.1–2.2 g/d) lowered total and LDL cholesterol in ApoE2 and ApoE3 carriers but not in ApoE4 carriers, and reduced certain serum carotenoids in some genotypes.

Trust comment: Large randomized controlled study with genotype stratification and objective measures, but responses varied by genotype limiting generalizability.

Study Details

PMID:19056656
Participants:217
Impact:Decreased in ApoE2 and ApoE3 subjects (P<0.05 vs control); no significant decrease in ApoE4 carriers
Trust score:4/5

Softgel capsules providing 1.8 g/d esterified plant sterols/stanols for 6 weeks reduced LDL, non-HDL and total cholesterol in adults with primary hypercholesterolemia.

Trust comment: Randomized, placebo-controlled crossover with objective lipid endpoints but small sample (n=28) and short treatment periods.

Study Details

PMID:22796122
Participants:28
Impact:-9.2% vs control
Trust score:4/5

Daily 2 g plant sterols in a yogurt-drink for 6–12 months significantly reduced small dense LDL-C and lowered LDL-C and total cholesterol in hypercholesterolemic children.

Trust comment: Prospective pediatric study with objective endpoints and clinically relevant follow-up but open-label design and modest completed sample (n=25) increase risk of bias.

Study Details

PMID:24887013
Participants:25
Impact:Median decrease 13% (≈-13%)
Trust score:3/5

1.5 g/d phytosterol capsules added to NCEP Step 2 diet for 8 weeks did not reduce LDL-C or other measured metabolic parameters in children/adolescents with dyslipidemia.

Trust comment: Randomized double-blind crossover pediatric RCT with good adherence to capsules but limited by short duration and low diet adherence as noted by authors.

Study Details

PMID:33290971
Participants:31
Impact:No significant change (rate of change not different vs control; p=0.30)
Trust score:4/5

Small dense LDL-cholesterol (sdLDL-C)

1 evidences

Daily 2 g plant sterols in a yogurt-drink for 6–12 months significantly reduced small dense LDL-C and lowered LDL-C and total cholesterol in hypercholesterolemic children.

Trust comment: Prospective pediatric study with objective endpoints and clinically relevant follow-up but open-label design and modest completed sample (n=25) increase risk of bias.

Study Details

PMID:24887013
Participants:25
Impact:Median decrease 16.6% (p<0.001)
Trust score:3/5

Cholesterol absorption (metabolism)

1 evidences

Sitostanol-ester margarine (3 g/d) reduced total and LDL cholesterol in postmenopausal women, including when combined with statin therapy.

Trust comment: Randomized, double-blind crossover trial in clinical population with clear biochemical outcomes, but modest sample size.

Study Details

PMID:9416886
Participants:32
Impact:Absorption -45%; fecal neutral sterol elimination +45%; synthesis +39%
Trust score:4/5

ApoB / non-HDL cholesterol

1 evidences

A Mediterranean low-glycemic diet improved metabolic syndrome variables; adding a phytochemical-rich medical food containing phytosterols led to greater improvements in LDL and related lipoprotein markers and lowered homocysteine.

Trust comment: Randomized 2-arm trial with adequate sample size and clinically relevant endpoints, though phytosterols were part of a multi-ingredient medical food.

Study Details

PMID:21600524
Participants:89
Impact:Greater reduction in intervention arm (P < .05)
Trust score:4/5

homocysteine

2 evidences

Daily fortified milk (including phytosterols) plus lifestyle counselling for 3 months improved several CVD-related markers (lower homocysteine, higher folate/B12) and tended to improve LDL:HDL; effects are from combined intervention.

Trust comment: Randomized with adequate sample but phytosterols were given within a multi-nutrient fortified milk plus lifestyle counselling, so effects cannot be attributed solely to phytosterols.

Study Details

PMID:23249766
Participants:101
Impact:significant decrease in enriched milk group vs placebo and control (P<0.001)
Trust score:3/5

A Mediterranean low-glycemic diet improved metabolic syndrome variables; adding a phytochemical-rich medical food containing phytosterols led to greater improvements in LDL and related lipoprotein markers and lowered homocysteine.

Trust comment: Randomized 2-arm trial with adequate sample size and clinically relevant endpoints, though phytosterols were part of a multi-ingredient medical food.

Study Details

PMID:21600524
Participants:89
Impact:Reduced in intervention arm vs control (P < .01)
Trust score:4/5

Triglycerides (TAG)

2 evidences

Daily intake of 2 g plant sterols reduced LDL-C and triglycerides in mildly hypercholesterolaemic adults; fish oil mainly reduced TAG and increased HDL; combination lowered TAG without interaction on cholesterol.

Trust comment: Large (n=200), double-blind randomized 2x2 factorial trial with clear effects on lipids but short duration (4 weeks).

Study Details

PMID:19296875
Participants:200
Impact:-15% (plant sterols main effect)
Trust score:4/5

Plant stanol (2.5 g/day) margarine for 3 weeks lowered total and LDL cholesterol and reduced triglycerides especially in subjects with high baseline TAG.

Trust comment: Randomized placebo-controlled study but small sample (n=28) and subgroup effects reported.

Study Details

PMID:19904567
Participants:28
Impact:decreased (significant in subjects with baseline TAG >2.3 mmol/L)
Trust score:3/5

Serum vitamin E / carotenoids

1 evidences

Daily low-fat milk with free plant sterols for 4 weeks reduced LDL cholesterol in mildly hypercholesterolemic adults.

Trust comment: Randomized, double-blind, placebo-controlled crossover with 71 completers; well-conducted but moderate sample size.

Study Details

PMID:15164106
Participants:71
Impact:no significant change vs baseline after LDL-standardization
Trust score:4/5

sitosterol (plasma)

1 evidences

Two years of ezetimibe 10 mg/day in homozygous sitosterolemia markedly lowered circulating plant sterols (sitosterol, campesterol) and modestly lowered LDL-related sterols and apoB.

Trust comment: Open-label extension in a rare disease with small N but consistent, large biomarker changes and reasonable follow-up supports good internal validity.

Study Details

PMID:18822021
Participants:21
Impact:−43.9% from baseline (p<0.001)
Trust score:4/5

campesterol (plasma)

2 evidences

Two years of ezetimibe 10 mg/day in homozygous sitosterolemia markedly lowered circulating plant sterols (sitosterol, campesterol) and modestly lowered LDL-related sterols and apoB.

Trust comment: Open-label extension in a rare disease with small N but consistent, large biomarker changes and reasonable follow-up supports good internal validity.

Study Details

PMID:18822021
Participants:21
Impact:−50.8% from baseline (p<0.001)
Trust score:4/5

Dalcetrapib treatment in patients raised HDL and increased campesterol only in certain patient subgroups (FCH, not FHA).

Trust comment: 4-week double-blind crossover in 40 patients; well-controlled but small and studies a drug effect on phytosterol levels rather than phytosterol supplementation.

Study Details

PMID:25281277
Participants:40
Impact:+25.0% (increased in FCH only)
Trust score:3/5

LDL sterols

1 evidences

Two years of ezetimibe 10 mg/day in homozygous sitosterolemia markedly lowered circulating plant sterols (sitosterol, campesterol) and modestly lowered LDL-related sterols and apoB.

Trust comment: Open-label extension in a rare disease with small N but consistent, large biomarker changes and reasonable follow-up supports good internal validity.

Study Details

PMID:18822021
Participants:21
Impact:−13.1% from baseline (p<0.05)
Trust score:4/5

total sterols

1 evidences

Two years of ezetimibe 10 mg/day in homozygous sitosterolemia markedly lowered circulating plant sterols (sitosterol, campesterol) and modestly lowered LDL-related sterols and apoB.

Trust comment: Open-label extension in a rare disease with small N but consistent, large biomarker changes and reasonable follow-up supports good internal validity.

Study Details

PMID:18822021
Participants:21
Impact:−10.3% from baseline (p<0.05)
Trust score:4/5

LDL cholesterol change (responders vs nonresponders)

1 evidences

In pooled clinical studies, people who did not lower LDL with plant sterols had higher baseline cholesterol synthesis; responders had ~−15% LDL while nonresponders had minor change (~+3.7%).

Trust comment: Large pooled clinical dataset with supporting animal models; strong internal consistency though heterogeneity across studies may exist.

Study Details

PMID:20444957
Participants:113
Impact:Responders: −15.16±1.04% vs Nonresponders: +3.73±1.10%
Trust score:4/5

basal cholesterol fractional synthesis rate (FSR)

1 evidences

In pooled clinical studies, people who did not lower LDL with plant sterols had higher baseline cholesterol synthesis; responders had ~−15% LDL while nonresponders had minor change (~+3.7%).

Trust comment: Large pooled clinical dataset with supporting animal models; strong internal consistency though heterogeneity across studies may exist.

Study Details

PMID:20444957
Participants:113
Impact:23% higher in nonresponders vs responders (P=0.003)
Trust score:4/5

HDL2 (subfraction)

1 evidences

Crossover trial: fish-oil–ester plant sterols lowered triglycerides markedly and plant sterol esters lowered LDL and apoB compared with control oil.

Trust comment: Small, semi-randomized single-blind crossover with multiple interventions; physiological endpoints measured but limited sample size.

Study Details

PMID:17158440
Participants:21
Impact:HDL2 and HDL2/HDL3 ratio increased after FO-PS vs other treatments
Trust score:3/5

Carotid artery compliance (CAC)

1 evidences

Three-month randomized study: plant stanol esters (2 g/day) lowered LDL-C but produced no overall change in arterial elasticity or endothelial function; subjects with low baseline values improved.

Trust comment: Large randomized trial with objective vascular and lipid endpoints; subgroup effects reported and overall vascular effects were null.

Study Details

PMID:18279553
Participants:200
Impact:No overall change; in low-baseline subgroup CAC improved from 1.23 to 1.59 % per 10 mmHg (treatment) vs 1.42 to 1.47 in controls (P = 0.0035)
Trust score:4/5

Total cholesterol reduction

1 evidences

Genetic study: CYP7A1 -204A>C variant associated with larger cholesterol lowering response to plant sterols and increased markers of cholesterol synthesis in C-allele carriers.

Trust comment: Moderate-sized human genetic association supported by cellular promoter assays; provides mechanistic linkage but not a large clinical trial.

Study Details

PMID:20884100
Participants:67
Impact:Adjusted mean reduction greater in C-carriers (0.43 mmol/L) vs AA subjects (0.14 mmol/L)
Trust score:3/5

Lathosterol-to-cholesterol ratio (cholesterol synthesis marker)

1 evidences

Genetic study: CYP7A1 -204A>C variant associated with larger cholesterol lowering response to plant sterols and increased markers of cholesterol synthesis in C-allele carriers.

Trust comment: Moderate-sized human genetic association supported by cellular promoter assays; provides mechanistic linkage but not a large clinical trial.

Study Details

PMID:20884100
Participants:67
Impact:Increase greater in C-carriers (0.75) vs AA (0.10) after plant sterol intervention
Trust score:3/5

Serum PCSK9 concentration

1 evidences

Six-month randomized double-blind trial where 3 g/day plant stanol esters reduced LDL-C ~10% without changing serum PCSK9.

Trust comment: Well-powered randomized double-blind 6-month trial with clear lipid endpoint and appropriate assays.

Study Details

PMID:25857271
Participants:92
Impact:no change
Trust score:5/5

Proportion achieving LDL target

1 evidences

Forty-two-day randomized double-blind trial where 1.6 g/day phytosterol yogurt reduced LDL-C ~10–12%, lowered triglycerides, and increased the proportion reaching LDL targets.

Trust comment: Multicentre randomized double-blind placebo-controlled trial with clinically relevant endpoints and good sample size.

Study Details

PMID:18193377
Participants:83
Impact:increase from 20% to 50% (+30 percentage points)
Trust score:5/5

VLDL-cholesterol (larger particles)

1 evidences

In hypercholesterolemic adults, a low-fat spread with plant sterols reduced LDL cholesterol and triglycerides; adding EPA+DHA further reduced VLDL components.

Trust comment: Large randomized double-blind parallel trial; short treatment (4 weeks) and combined interventions limit attribution solely to plant sterols.

Study Details

PMID:26019023
Participants:282
Impact:dose-dependent reduction with added EPA+DHA
Trust score:4/5

Serum plant sterols (indicator of absorption)

1 evidences

One-year sitostanol-ester margarine use lowered markers of cholesterol absorption and reduced serum beta-carotene but did not change vitamin D or retinol.

Trust comment: Long (1-year) controlled human study with adequate sample size; some imbalance in group sizes but measurements and duration are appropriate.

Study Details

PMID:10488954
Participants:151
Impact:reduced up to -38% vs controls (P<0.01)
Trust score:4/5

HAV antibody titres

1 evidences

In asthma patients, 4 g/day plant stanol esters for 8 weeks increased hepatitis A vaccine antibody titres and reduced total IgE and some proinflammatory cytokines versus control.

Trust comment: Randomized, double-blind, placebo-controlled trial (n=58) with clinically relevant immune endpoints; moderate-high confidence though specific cytokine findings were partially inconsistent.

Study Details

PMID:26762374
Participants:58
Impact:increase +19% (week 3) and +22% (week 4) after vaccination in plant stanol group
Trust score:4/5

total IgE

1 evidences

In asthma patients, 4 g/day plant stanol esters for 8 weeks increased hepatitis A vaccine antibody titres and reduced total IgE and some proinflammatory cytokines versus control.

Trust comment: Randomized, double-blind, placebo-controlled trial (n=58) with clinically relevant immune endpoints; moderate-high confidence though specific cytokine findings were partially inconsistent.

Study Details

PMID:26762374
Participants:58
Impact:substantial decrease (plant stanol group vs control)
Trust score:4/5

proinflammatory cytokines

1 evidences

In asthma patients, 4 g/day plant stanol esters for 8 weeks increased hepatitis A vaccine antibody titres and reduced total IgE and some proinflammatory cytokines versus control.

Trust comment: Randomized, double-blind, placebo-controlled trial (n=58) with clinically relevant immune endpoints; moderate-high confidence though specific cytokine findings were partially inconsistent.

Study Details

PMID:26762374
Participants:58
Impact:decreases in IL-1β and TNF-α (plant stanol group)
Trust score:4/5

Plasma sitosterol and campesterol

1 evidences

Both stanol-ester and sterol-ester margarines (~2 g/d) consumed for 4 weeks reduced total and LDL cholesterol similarly; sterol esters increased serum sitosterol and campesterol.

Trust comment: Randomized, double-blind Latin-square repeated measures design with 34 completers showing consistent cholesterol reductions.

Study Details

PMID:11002384
Participants:34
Impact:increased with STEEST (sitosterol +0.83 mg/L; campesterol +2.77 mg/L)
Trust score:4/5

faecal neutral sterols

1 evidences

Consuming margarine enriched with phytosterol esters markedly increased faecal neutral sterol excretion and modestly reduced secondary bile acids, with no increase in sterol oxides.

Trust comment: Controlled-diet human study (n=24) with direct biochemical measures; small sample but well-controlled.

Study Details

PMID:10566877
Participants:24
Impact:increase from ~40 mg/g to ~190 mg/g dry feces (≈+150 mg/g)
Trust score:4/5

faecal neutral sterol metabolites

1 evidences

Consuming margarine enriched with phytosterol esters markedly increased faecal neutral sterol excretion and modestly reduced secondary bile acids, with no increase in sterol oxides.

Trust comment: Controlled-diet human study (n=24) with direct biochemical measures; small sample but well-controlled.

Study Details

PMID:10566877
Participants:24
Impact:increase from ~30 mg/g to ~50 mg/g dry feces (+~20 mg/g)
Trust score:4/5

faecal secondary bile acids

1 evidences

Consuming margarine enriched with phytosterol esters markedly increased faecal neutral sterol excretion and modestly reduced secondary bile acids, with no increase in sterol oxides.

Trust comment: Controlled-diet human study (n=24) with direct biochemical measures; small sample but well-controlled.

Study Details

PMID:10566877
Participants:24
Impact:decrease from 7.6 mg/g to 6.0 mg/g dry feces (−1.6 mg/g)
Trust score:4/5

Circulating plant sterols (campesterol+β-sitosterol)

1 evidences

Heterozygotes and controls took ~1.6 g/day plant sterols for 4 weeks; LDL fell in both groups while plant sterol levels rose and absorption decreased with compensatory synthesis increase.

Trust comment: Randomized, double-blind, crossover placebo-controlled study with direct kinetic measures; small sample but rigorous methods.

Study Details

PMID:22378727
Participants:25
Impact:increase (HET +12.4 μmol/L; control +2.9 μmol/L)
Trust score:4/5

hsCRP

1 evidences

A spread with plant stanol esters (2 g/d) rapidly lowered cholesterol, hsCRP, and estimated cardiovascular risk compared with placebo.

Trust comment: Prospective randomized placebo‑controlled study with adequate sample size and clinically relevant endpoints.

Study Details

PMID:19939653
Participants:150
Impact:−17% (1 month)
Trust score:4/5

estimated cardiovascular risk

1 evidences

A spread with plant stanol esters (2 g/d) rapidly lowered cholesterol, hsCRP, and estimated cardiovascular risk compared with placebo.

Trust comment: Prospective randomized placebo‑controlled study with adequate sample size and clinically relevant endpoints.

Study Details

PMID:19939653
Participants:150
Impact:−26% to −30% (1 month, various risk engines)
Trust score:4/5

serum plant sterols (campesterol, sitosterol)

1 evidences

In hypercholesterolemic subjects, oat-bran produced a transient total cholesterol decrease but did not change serum plant sterol proportions or cholesterol synthesis precursors substantially.

Trust comment: Randomized dietary intervention (n=36) with post-hoc sterol analyses; modest size and some outcomes transient, limiting strength.

Study Details

PMID:9306087
Participants:36
Impact:no significant change (proportions unchanged)
Trust score:3/5

serum sitosterol and campesterol

1 evidences

Adding plant sterol or stanol esters for 16 weeks increased serum plant sterols but did not change red blood cell sterol content or osmotic fragility in statin-treated patients.

Trust comment: Double-blind randomized placebo-controlled trial in statin-treated patients (n=41); adequate design though modest sample size.

Study Details

PMID:16482072
Participants:41
Impact:+42% (sitosterol) and +59% (campesterol) vs control (cholesterol-standardized)
Trust score:4/5

erythrocyte campesterol

1 evidences

Adding plant sterol or stanol esters for 16 weeks increased serum plant sterols but did not change red blood cell sterol content or osmotic fragility in statin-treated patients.

Trust comment: Double-blind randomized placebo-controlled trial in statin-treated patients (n=41); adequate design though modest sample size.

Study Details

PMID:16482072
Participants:41
Impact:no significant change
Trust score:4/5

erythrocyte osmotic fragility

1 evidences

Adding plant sterol or stanol esters for 16 weeks increased serum plant sterols but did not change red blood cell sterol content or osmotic fragility in statin-treated patients.

Trust comment: Double-blind randomized placebo-controlled trial in statin-treated patients (n=41); adequate design though modest sample size.

Study Details

PMID:16482072
Participants:41
Impact:no significant change
Trust score:4/5

plant sterols in triglyceride-rich lipoproteins (chylomicrons, VLDL)

1 evidences

In subjects consuming plant stanol esters long-term, an acute stanol dose reduced certain plant sterols in triglyceride-rich lipoproteins and altered postprandial sterol markers.

Trust comment: Randomized double-blind intervention with lipoprotein separation and sterol assays (n=38); good mechanistic data though sample size modest.

Study Details

PMID:21947207
Participants:38
Impact:reduced at 0 h in staest group vs controls (chronic staest)
Trust score:4/5

postprandial cholestenol in chylomicrons

1 evidences

In subjects consuming plant stanol esters long-term, an acute stanol dose reduced certain plant sterols in triglyceride-rich lipoproteins and altered postprandial sterol markers.

Trust comment: Randomized double-blind intervention with lipoprotein separation and sterol assays (n=38); good mechanistic data though sample size modest.

Study Details

PMID:21947207
Participants:38
Impact:decrease: -0.13 ± 0.04 μg/dL (staest) vs 0.01 ± 0.08 μg/dL (control)
Trust score:4/5

sitostanol in VLDL (postprandial)

1 evidences

In subjects consuming plant stanol esters long-term, an acute stanol dose reduced certain plant sterols in triglyceride-rich lipoproteins and altered postprandial sterol markers.

Trust comment: Randomized double-blind intervention with lipoprotein separation and sterol assays (n=38); good mechanistic data though sample size modest.

Study Details

PMID:21947207
Participants:38
Impact:increased postprandially with acute staest
Trust score:4/5

LDL cholesterol (ezetimibe vs control)

1 evidences

In >1000 elderly patients (analysis n=1061), higher baseline campesterol was associated with fewer cardiovascular events; ezetimibe markedly lowered LDL-C and cholesterol absorption markers at 24 weeks.

Trust comment: Large randomized multicenter trial substudy with clinical endpoints and biomarker measures; high internal validity though limited to Japanese patients ≥75 years.

Study Details

PMID:38240241
Participants:1061
Impact:−14.8% vs −1.9% at 24 weeks
Trust score:4/5

Campesterol (ezetimibe change)

1 evidences

In >1000 elderly patients (analysis n=1061), higher baseline campesterol was associated with fewer cardiovascular events; ezetimibe markedly lowered LDL-C and cholesterol absorption markers at 24 weeks.

Trust comment: Large randomized multicenter trial substudy with clinical endpoints and biomarker measures; high internal validity though limited to Japanese patients ≥75 years.

Study Details

PMID:38240241
Participants:1061
Impact:−45.5% at 24 weeks
Trust score:4/5

Baseline campesterol and CVE risk

1 evidences

In >1000 elderly patients (analysis n=1061), higher baseline campesterol was associated with fewer cardiovascular events; ezetimibe markedly lowered LDL-C and cholesterol absorption markers at 24 weeks.

Trust comment: Large randomized multicenter trial substudy with clinical endpoints and biomarker measures; high internal validity though limited to Japanese patients ≥75 years.

Study Details

PMID:38240241
Participants:1061
Impact:highest quartile HR ≈0.44 vs lowest quartile (reduced risk)
Trust score:4/5

lipophilic (pro)vitamins

1 evidences

In 68 healthy people, rye bread with 2–4 g/day plant sterols for short treatment periods lowered total and LDL cholesterol and improved apoB/apoA1 and cholesterol/HDL ratios without affecting fat‑soluble vitamins.

Trust comment: Double-blind dietary intervention in humans with objective lipid outcomes, though sample size moderate and treatment periods brief.

Study Details

PMID:21215605
Participants:68
Impact:no change
Trust score:4/5

Lipid peroxidation (LDL susceptibility)

1 evidences

In 21 overweight people with high cholesterol, olive-oil-esterified plant sterols reduced LDL and (for the olive-oil formulation) decreased LDL susceptibility to peroxidation.

Trust comment: Randomized crossover in humans with 28-day periods but small sample and limited magnitude reporting.

Study Details

PMID:17559697
Participants:21
Impact:decrease (P=0.0097) with PS-OO treatment
Trust score:3/5

Max urinary flow (Qmed)

1 evidences

In 36 BPH patients, a 3-month Difaprost® (contains β-sitosterol among other agents) course showed non-significant improvements in urine residual and flow and reduced some histologic edema.

Trust comment: Randomized clinical trial in humans but small sample, combination product (multiple active agents) and mostly non-significant clinical changes.

Study Details

PMID:24988203
Participants:36
Impact:+0.9 mL/s (5.6 → 6.5 mL/s; P=0.9, not significant)
Trust score:3/5

Histologic edema/angiectasia

1 evidences

In 36 BPH patients, a 3-month Difaprost® (contains β-sitosterol among other agents) course showed non-significant improvements in urine residual and flow and reduced some histologic edema.

Trust comment: Randomized clinical trial in humans but small sample, combination product (multiple active agents) and mostly non-significant clinical changes.

Study Details

PMID:24988203
Participants:36
Impact:reduced presence (not statistically significant)
Trust score:3/5

total plasma carotenoids

1 evidences

Consuming plant sterol ester-enriched salad dressings (3.6 g/d) lowered LDL and triglycerides but also reduced plasma carotenoids in mildly hypercholesterolemic adults.

Trust comment: Controlled, randomized crossover feeding study with well-measured endpoints though short duration and modest sample size.

Study Details

PMID:11876261
Participants:53
Impact:-9.6%
Trust score:4/5

Fat-soluble vitamins

1 evidences

Daily spreads with microcrystalline plant sterols (1.5–3.0 g/day) lowered total and LDL cholesterol over 6 months with no apparent adverse effects on fat‑soluble vitamins.

Trust comment: Large double-blind, randomized, placebo-controlled 6‑month trial with clinically relevant endpoints and adequate sample size.

Study Details

PMID:11518201
Participants:155
Impact:no decrease observed
Trust score:5/5

serum cholesterol (response)

1 evidences

One-year stanol-ester margarine feeding lowered serum cholesterol in most participants and changed markers of cholesterol absorption and synthesis.

Trust comment: Large 1-year human feeding study with analytical sterol measurements; moderate-high reliability.

Study Details

PMID:10191283
Participants:153
Impact:reduced in ~88% of participants; +5% when dose reduced from 3 to 2 g/day
Trust score:4/5

non-cholesterol sterol proportions (campesterol, sitosterol, cholestanol)

1 evidences

One-year stanol-ester margarine feeding lowered serum cholesterol in most participants and changed markers of cholesterol absorption and synthesis.

Trust comment: Large 1-year human feeding study with analytical sterol measurements; moderate-high reliability.

Study Details

PMID:10191283
Participants:153
Impact:decreased 5–39%
Trust score:4/5

precursor sterol proportions (cholesterol synthesis markers)

1 evidences

One-year stanol-ester margarine feeding lowered serum cholesterol in most participants and changed markers of cholesterol absorption and synthesis.

Trust comment: Large 1-year human feeding study with analytical sterol measurements; moderate-high reliability.

Study Details

PMID:10191283
Participants:153
Impact:increased 10–46%
Trust score:4/5

plasma 8-isoprostane

1 evidences

Six weeks of daily phytosterol-enriched low-fat fermented milk lowered total and LDL cholesterol and reduced a plasma isoprostane marker of oxidative burden.

Trust comment: Multicenter randomized double-blind design with clear lipid and oxidative marker changes over 6 weeks.

Study Details

PMID:18762410
Participants:116
Impact:-~11.7% (from 43.07 to 38.04 pg/ml)
Trust score:4/5

cholesterol in LDL particles (small/medium/large)

1 evidences

Over 8 weeks, plant sterol supplementation reduced cholesterol content within LDL subfractions (~13–14%) but did not change LDL size distribution; exercise altered LDL size slightly.

Trust comment: Placebo-controlled randomized trial but short duration and mixed interventions complicate attribution to sterols alone.

Study Details

PMID:15674305
Participants:84
Impact:decreased 13.4–14.4% across sizes
Trust score:3/5

LDL peak particle size

1 evidences

Over 8 weeks, plant sterol supplementation reduced cholesterol content within LDL subfractions (~13–14%) but did not change LDL size distribution; exercise altered LDL size slightly.

Trust comment: Placebo-controlled randomized trial but short duration and mixed interventions complicate attribution to sterols alone.

Study Details

PMID:15674305
Participants:84
Impact:exercise: decreased from 255 to 253 Å (small change); sterols: no change
Trust score:3/5

Plasma sitosterol concentration

1 evidences

Checklist: - Confirm human randomized trial of plant sterol–enriched low-fat fermented milk; - Extract main outcomes (LDL-C, oxidized LDL, plasma sitosterol); - Record participant count and numeric changes and safety markers. Simple summary: In hypercholesterolemic adults, daily low-fat fermented milk with plant sterols (1.6 g/day) reduced LDL cholesterol and oxidized LDL and raised plasma sitosterol without adverse oxidative-stress signals.

Trust comment: Large randomized controlled study (n=194) with objective biochemical endpoints and clear reporting.

Study Details

PMID:17823447
Participants:194
Impact:Increased by 35%
Trust score:4/5

Triglycerides (fasting and postprandial)

1 evidences

Checklist: - Confirm human crossover trial comparing PS esters with different fatty-acid carriers (sunflower, olive, fish oil); - Extract main outcomes (LDL-C, triglycerides, PAI-1) and their numeric changes; - Note sample size, crossover design, and industry involvement when assessing trust. Simple summary: In a small crossover study, plant sterol esters carried by fish oil lowered triglycerides and PAI-1 more than vegetable-oil carriers; all PS treatments lowered cholesterol versus baseline.

Trust comment: Small, well-controlled crossover human trial (n=21) with multiple outcomes and declared industry involvement, limiting generalizability.

Study Details

PMID:17961204
Participants:21
Impact:PS-FO fasting 0.99 mmol/L vs PS-SO 1.62 and PS-OO 1.75 (significantly lower); postprandial PS-FO 1.53 vs PS-SO 2.56 and PS-OO 2.70
Trust score:3/5

PAI-1 concentration

1 evidences

Checklist: - Confirm human crossover trial comparing PS esters with different fatty-acid carriers (sunflower, olive, fish oil); - Extract main outcomes (LDL-C, triglycerides, PAI-1) and their numeric changes; - Note sample size, crossover design, and industry involvement when assessing trust. Simple summary: In a small crossover study, plant sterol esters carried by fish oil lowered triglycerides and PAI-1 more than vegetable-oil carriers; all PS treatments lowered cholesterol versus baseline.

Trust comment: Small, well-controlled crossover human trial (n=21) with multiple outcomes and declared industry involvement, limiting generalizability.

Study Details

PMID:17961204
Participants:21
Impact:PS-FO 20.5 µg/L vs PS-SO 40.3 µg/L (lowered; P = 0.0297)
Trust score:3/5

Plasma beta-sitosterol

1 evidences

Checklist: - Confirm human semirandomized double-blind crossover trial testing free plant sterols with high vs low dietary cholesterol; - Extract main outcomes (LDL-C, total cholesterol, plasma beta-sitosterol); - Note participant count and interaction results. Simple summary: In a 22-person crossover trial, plant sterol supplementation lowered cholesterol independent of dietary cholesterol level and increased plasma beta-sitosterol.

Trust comment: Small, controlled crossover RCT with clear design but limited sample size and incomplete numerical details in the provided text.

Study Details

PMID:18249205
Participants:22
Impact:Increased (P < .0001)
Trust score:3/5

endothelial function

1 evidences

Checklist: - Confirm human randomized crossover dietary intervention in familial hypercholesterolemia (FH); - Extract main outcomes (LDL-C response, endothelial function, LDL particle size), focusing on LDL changes by baseline sitosterol tertiles; - Record numerical LDL changes per tertile. Simple summary: In FH patients, baseline plasma sitosterol levels predicted LDL response to sitosterol-enriched diets: those with higher basal sitosterol had larger LDL reductions.

Trust comment: Randomized crossover in FH patients (n=30) with clear tertile-based LDL responses, but moderate sample size limits power.

Study Details

PMID:17440528
Participants:30
Impact:Measured but no clear quantitative effect reported in provided text
Trust score:3/5

LDL particle size

1 evidences

Checklist: - Confirm human randomized crossover dietary intervention in familial hypercholesterolemia (FH); - Extract main outcomes (LDL-C response, endothelial function, LDL particle size), focusing on LDL changes by baseline sitosterol tertiles; - Record numerical LDL changes per tertile. Simple summary: In FH patients, baseline plasma sitosterol levels predicted LDL response to sitosterol-enriched diets: those with higher basal sitosterol had larger LDL reductions.

Trust comment: Randomized crossover in FH patients (n=30) with clear tertile-based LDL responses, but moderate sample size limits power.

Study Details

PMID:17440528
Participants:30
Impact:Measured but no clear quantitative effect reported in provided text
Trust score:3/5

serum campesterol (cholesterol absorption marker)

1 evidences

Replacing part of daily fat with sitostanol-ester margarine for one year lowered total and LDL cholesterol and was well tolerated.

Trust comment: One-year randomized double-blind trial (n=153) with clear significant cholesterol reductions and good design.

Study Details

PMID:7566021
Participants:153
Impact:-36%
Trust score:5/5

Plasma carotenoids (overall)

1 evidences

In hypercholesterolemic subjects, spreads with plant sterol/stanol esters lowered LDL (~7.7–9.5%) while dietary advice to add a high-carotenoid serving maintained plasma carotenoids.

Trust comment: Double-blind randomized crossover (n=46) with clear biochemical endpoints; adequate design though sample modest.

Study Details

PMID:11756063
Participants:46
Impact:maintained with added high-carotenoid serving (no significant decrease)
Trust score:4/5

Small dense LDL (sdLDL)

1 evidences

In 28 adults with elevated LDL, eating two servings/day of pistachios reduced small, dense LDL and improved some cholesterol efflux measures; β‑sitosterol levels rose, confirming intake.

Trust comment: Randomized, controlled cross-over feeding study with rigorous diet control but small sample size.

Study Details

PMID:25008473
Participants:28
Impact:decrease (2PD vs control; P=0.001)
Trust score:4/5

TAG:HDL ratio

1 evidences

In 28 adults with elevated LDL, eating two servings/day of pistachios reduced small, dense LDL and improved some cholesterol efflux measures; β‑sitosterol levels rose, confirming intake.

Trust comment: Randomized, controlled cross-over feeding study with rigorous diet control but small sample size.

Study Details

PMID:25008473
Participants:28
Impact:decrease (2PD vs control; P=0.036)
Trust score:4/5

β-sitosterol (serum)

2 evidences

In 28 adults with elevated LDL, eating two servings/day of pistachios reduced small, dense LDL and improved some cholesterol efflux measures; β‑sitosterol levels rose, confirming intake.

Trust comment: Randomized, controlled cross-over feeding study with rigorous diet control but small sample size.

Study Details

PMID:25008473
Participants:28
Impact:increase (P<0.0001)
Trust score:4/5

- Checklist: - Confirm randomized prospective human study in infants and outcomes (serum plant sterols, cholesterol precursors). - Extract participant numbers and percent changes in sterols. - Assess quality briefly. Doubling dietary plant sterols in 13-month-old children nearly doubled serum plant sterol levels (campesterol and sitosterol) but did not change markers of cholesterol synthesis.

Trust comment: Randomized prospective STRIP study with clear biochemical measurements in young children; moderate sample size.

Study Details

PMID:11435511
Participants:40
Impact:+44%
Trust score:4/5

Combined LDL reduction (sterol + cerivastatin)

1 evidences

In 152 adults with primary hypercholesterolemia, sterol‑ester margarine lowered LDL by ~8%; combined with cerivastatin the LDL reduction was additive (~39% combined).

Trust comment: Multicenter, randomized double-blind trial with adequate sample size and clear LDL outcomes, though short duration (4 weeks).

Study Details

PMID:12356387
Participants:152
Impact:−39% (additive effect)
Trust score:4/5

low-density lipoprotein cholesterol (LDL-C)

2 evidences

Healthy young men replaced butter with sterol margarine; LDL fell, platelets were less sticky, fibrinogen rose slightly.

Trust comment: Randomized controlled trial with clear lipid and platelet endpoints but small, homogeneous sample of young men.

Study Details

PMID:14624393
Participants:42
Impact:-11%
Trust score:4/5

Children with familial hypercholesterolemia given plant sterols had lower cholesterol but no short-term improvement in blood vessel function.

Trust comment: Double-blind crossover trial in 41 children with clear lipid outcomes but short treatment period and pediatric-specific sample.

Study Details

PMID:12971422
Participants:41
Impact:-14%
Trust score:4/5

Fibrinogen concentration

1 evidences

Healthy young men replaced butter with sterol margarine; LDL fell, platelets were less sticky, fibrinogen rose slightly.

Trust comment: Randomized controlled trial with clear lipid and platelet endpoints but small, homogeneous sample of young men.

Study Details

PMID:14624393
Participants:42
Impact:increased
Trust score:4/5

Platelet adhesion/aggregation time

1 evidences

Healthy young men replaced butter with sterol margarine; LDL fell, platelets were less sticky, fibrinogen rose slightly.

Trust comment: Randomized controlled trial with clear lipid and platelet endpoints but small, homogeneous sample of young men.

Study Details

PMID:14624393
Participants:42
Impact:prolonged (antiplatelet effect)
Trust score:4/5

LDL cholesterol (plant sterols alone)

1 evidences

In 4-week treatment periods, plant sterols and ezetimibe each lowered LDL-C; combination reduced LDL-C most versus placebo but offered no clear benefit over ezetimibe alone.

Trust comment: Randomized, double-blind placebo-controlled crossover for plant sterol component with open-label ezetimibe; moderate sample and clear lipid measures.

Study Details

PMID:16162943
Participants:40
Impact:-0.23 mmol/L (-4.7%)
Trust score:4/5

LDL cholesterol (ezetimibe alone)

1 evidences

In 4-week treatment periods, plant sterols and ezetimibe each lowered LDL-C; combination reduced LDL-C most versus placebo but offered no clear benefit over ezetimibe alone.

Trust comment: Randomized, double-blind placebo-controlled crossover for plant sterol component with open-label ezetimibe; moderate sample and clear lipid measures.

Study Details

PMID:16162943
Participants:40
Impact:-0.94 mmol/L (-22.2%)
Trust score:4/5

Beta-carotene to LDL ratio

1 evidences

Checklist: - Confirm human RCT testing plant stanol (phytosterol) effect in children; - Extract main measured outcomes (total cholesterol, LDL-C, beta-carotene/LDL ratio); - Record participant count and numerical changes; assess study quality quickly. Simple summary: In a double-blind crossover trial in 6-year-old children, replacing fat with plant stanol–enriched margarine slightly lowered total and LDL cholesterol but reduced beta-carotene/LDL ratio.

Trust comment: Well-conducted double-blind randomized crossover trial in children with intention-to-treat analysis and clear numerical outcomes.

Study Details

PMID:10753249
Participants:81
Impact:-19%
Trust score:4/5

Cholesterol in small LDL subclass

1 evidences

A dietary portfolio including plant sterols reduced LDL-cholesterol comparably to a statin, largely by lowering cholesterol in the small LDL subclass (portfolio -0.69 mmol/L).

Trust comment: Within-subject randomized crossover (n=34) with direct biochemical measures; limited duration but robust design.

Study Details

PMID:17663803
Participants:34
Impact:-0.69 mmol/L (portfolio) vs -0.99 mmol/L (statin); control -0.17 mmol/L
Trust score:4/5

Overall LDL-cholesterol

1 evidences

A dietary portfolio including plant sterols reduced LDL-cholesterol comparably to a statin, largely by lowering cholesterol in the small LDL subclass (portfolio -0.69 mmol/L).

Trust comment: Within-subject randomized crossover (n=34) with direct biochemical measures; limited duration but robust design.

Study Details

PMID:17663803
Participants:34
Impact:reduced (magnitude comparable to statin over 4 weeks)
Trust score:4/5

LDL particle size phenotype (features)

1 evidences

A dietary portfolio including plant sterols reduced LDL-cholesterol comparably to a statin, largely by lowering cholesterol in the small LDL subclass (portfolio -0.69 mmol/L).

Trust comment: Within-subject randomized crossover (n=34) with direct biochemical measures; limited duration but robust design.

Study Details

PMID:17663803
Participants:34
Impact:only minor changes aside from small LDL cholesterol reduction
Trust score:4/5

Ubiquinol-10 (absolute concentration)

1 evidences

Plant stanol esters increased cholesterol synthesis, lowered cholesterol absorption and LDL, and reduced absolute plasma ubiquinol-10 (~12–15%) and several fat-soluble antioxidants (largest for hydrocarbon carotenoids).

Trust comment: Controlled dietary intervention with n=112 and measured biochemical endpoints; well-reported but focused on antioxidant consequences rather than clinical outcomes.

Study Details

PMID:11319712
Participants:112
Impact:-12.3% (vegetable-based stanol group), -15.4% (wood-based stanol group)
Trust score:4/5

Hydrocarbon carotenoids (beta-, alpha-carotene, lycopene) absolute concentrations

1 evidences

Plant stanol esters increased cholesterol synthesis, lowered cholesterol absorption and LDL, and reduced absolute plasma ubiquinol-10 (~12–15%) and several fat-soluble antioxidants (largest for hydrocarbon carotenoids).

Trust comment: Controlled dietary intervention with n=112 and measured biochemical endpoints; well-reported but focused on antioxidant consequences rather than clinical outcomes.

Study Details

PMID:11319712
Participants:112
Impact:decreased (largest reductions among antioxidants; % not specified)
Trust score:4/5

LDL-cholesterol-standardized ubiquinol-10

1 evidences

Plant stanol esters increased cholesterol synthesis, lowered cholesterol absorption and LDL, and reduced absolute plasma ubiquinol-10 (~12–15%) and several fat-soluble antioxidants (largest for hydrocarbon carotenoids).

Trust comment: Controlled dietary intervention with n=112 and measured biochemical endpoints; well-reported but focused on antioxidant consequences rather than clinical outcomes.

Study Details

PMID:11319712
Participants:112
Impact:no significant change
Trust score:4/5

Plaque macrophage content

1 evidences

In patients undergoing carotid surgery, cholestyramine plus sitosterol lowered LDL-C less than atorvastatin and plaques showed higher macrophage content versus high‑dose statin.

Trust comment: Randomized trial with histological endpoints in 60 patients; well-conducted but small and effects were influenced by differences in LDL‑C lowering.

Study Details

PMID:20413736
Participants:60
Impact:higher with cholestyramine+sitosterol vs atorvastatin (statin groups had lower macrophage content)
Trust score:4/5

C-reactive protein (hs-CRP)

1 evidences

In 72 healthy adults, a reduced-calorie orange juice with plant sterols (2 g/day) for 8 weeks lowered LDL (~9.4%), total cholesterol (~5%), and CRP (~12%) and increased HDL.

Trust comment: Randomized trial of moderate size with clear lipid and CRP changes; 8-week duration limits long-term inference.

Study Details

PMID:17023701
Participants:72
Impact:median −12% (P<0.005 vs baseline/placebo)
Trust score:4/5

Low-density lipoprotein cholesterol (LDL-C) (intake occasion)

1 evidences

A single-dose 3 g/day plant-sterol yoghurt drink lowered LDL more when taken with a meal than when taken alone.

Trust comment: Large double-blind randomized placebo-controlled trial with 184 completers and clear, clinically meaningful lipid outcomes.

Study Details

PMID:16234829
Participants:184
Impact:with meal: -9.5% (low-fat drink), -9.3% (higher-fat drink); without meal: -5.1% (low-fat), -6.9% (higher-fat)
Trust score:5/5

large VLDL (VLDL-1) particle concentration

1 evidences

- Checklist: - Confirm human intervention(s) and select top outcomes (non-HDL/LDL, TAG, VLDL particle counts). - Extract participant numbers per study and reported numeric changes. - Assess study design and report likely mechanisms discussed. Two controlled human intervention studies (metabolic syndrome and normolipidemic groups) showed that plant stanol esters lower cholesterol and, in subjects with high baseline TAG, markedly reduce triglycerides and large VLDL particles.

Trust comment: Two double-blind placebo-controlled trials with N reported and detailed lipoprotein profiling; mechanistic interpretation partly speculative.

Study Details

PMID:19856194
Participants:130
Impact:reduction (−3.8 ± 6.7 nmol/L in metabolic syndrome group)
Trust score:4/5

campesterol (serum)

1 evidences

- Checklist: - Confirm randomized prospective human study in infants and outcomes (serum plant sterols, cholesterol precursors). - Extract participant numbers and percent changes in sterols. - Assess quality briefly. Doubling dietary plant sterols in 13-month-old children nearly doubled serum plant sterol levels (campesterol and sitosterol) but did not change markers of cholesterol synthesis.

Trust comment: Randomized prospective STRIP study with clear biochemical measurements in young children; moderate sample size.

Study Details

PMID:11435511
Participants:40
Impact:+75%
Trust score:4/5

CETP concentration

1 evidences

In a 4-week crossover double-blind study, margarine with phytosterol esters lowered blood cholesterol levels, with genotype affecting the size of the effect.

Trust comment: Well-conducted double-blind crossover RCT with moderate sample and genotype stratification, providing reliable lipid outcome data.

Study Details

PMID:12771320
Participants:60
Impact:decreased (in II phenotype)
Trust score:4/5

HDL cholesterol / Triglycerides / Apolipoprotein B

1 evidences

Five-week randomized double-blind trial showed cheese with 2 g/day plant stanols lowered total and LDL cholesterol compared with control cheese.

Trust comment: Randomized double-blind parallel study with full completion and clear lipid endpoints; moderate sample gives reliable effect estimates.

Study Details

PMID:16721398
Participants:67
Impact:no significant change
Trust score:4/5

LDL cholesterol (plant sterol)

1 evidences

In 54 statin-treated patients over 85 weeks, plant sterol esters reduced LDL by ~0.28 mmol/L (~8.7%) and stanol esters by ~0.42 mmol/L (~13.1%).

Trust comment: Long (85‑week) randomized trial in statin users with consistent LDL reductions; moderate sample size limits precision for secondary endpoints.

Study Details

PMID:18846701
Participants:54
Impact:−0.28 mmol/L (≈−8.7%) after 85 weeks
Trust score:4/5

LDL cholesterol (plant stanol)

1 evidences

In 54 statin-treated patients over 85 weeks, plant sterol esters reduced LDL by ~0.28 mmol/L (~8.7%) and stanol esters by ~0.42 mmol/L (~13.1%).

Trust comment: Long (85‑week) randomized trial in statin users with consistent LDL reductions; moderate sample size limits precision for secondary endpoints.

Study Details

PMID:18846701
Participants:54
Impact:−0.42 mmol/L (≈−13.1%) after 85 weeks
Trust score:4/5

Oxysterols and bile acid synthesis marker

1 evidences

In 54 statin-treated patients over 85 weeks, plant sterol esters reduced LDL by ~0.28 mmol/L (~8.7%) and stanol esters by ~0.42 mmol/L (~13.1%).

Trust comment: Long (85‑week) randomized trial in statin users with consistent LDL reductions; moderate sample size limits precision for secondary endpoints.

Study Details

PMID:18846701
Participants:54
Impact:no significant change detected
Trust score:4/5

High-density lipoprotein cholesterol (HDL-C)

1 evidences

Dalcetrapib treatment in patients raised HDL and increased campesterol only in certain patient subgroups (FCH, not FHA).

Trust comment: 4-week double-blind crossover in 40 patients; well-controlled but small and studies a drug effect on phytosterol levels rather than phytosterol supplementation.

Study Details

PMID:25281277
Participants:40
Impact:+18–22% (increased vs placebo)
Trust score:3/5

endothelial function (flow-mediated dilation)

2 evidences

Children with familial hypercholesterolemia given plant sterols had lower cholesterol but no short-term improvement in blood vessel function.

Trust comment: Double-blind crossover trial in 41 children with clear lipid outcomes but short treatment period and pediatric-specific sample.

Study Details

PMID:12971422
Participants:41
Impact:no improvement
Trust score:4/5

- Checklist: - Confirm human study and outcomes (lipids, endothelial function). - Extract participant count and main outcomes (TC, LDL-C, FMD). - Report numeric changes, assess quality. Children with familial high cholesterol took yogurt with 2.0 g plant stanols daily; their LDL and total cholesterol fell but blood vessel function (FMD) did not improve.

Trust comment: Double-blind crossover RCT in children with clear numeric lipid and FMD results; moderate sample size.

Study Details

PMID:16647412
Participants:42
Impact:no change (10.5% vs 10.6%, P=0.852)
Trust score:4/5

cholesterol precursor sterols (Delta-8 cholestenol, desmosterol, lathosterol)

1 evidences

- Checklist: - Confirm randomized prospective human study in infants and outcomes (serum plant sterols, cholesterol precursors). - Extract participant numbers and percent changes in sterols. - Assess quality briefly. Doubling dietary plant sterols in 13-month-old children nearly doubled serum plant sterol levels (campesterol and sitosterol) but did not change markers of cholesterol synthesis.

Trust comment: Randomized prospective STRIP study with clear biochemical measurements in young children; moderate sample size.

Study Details

PMID:11435511
Participants:40
Impact:no change
Trust score:4/5