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β-Sitosterol (Plant Phytosterol)

Beta-Sitosterol

Research reviewed: Up until 03/2026

Beta-Sitosterol (β-Sitosterol (Plant Phytosterol)) is a dietary supplement with 14 published peer-reviewed studies involving 200 participants, researched for Benign Prostatic Hyperplasia (BPH), Cholesterol Management, Immune Modulation & Anti-inflammatory Activity and 2 more areas.

14
Studies
200
Participants
1997–2025
Research Span

Evidence at a Glance

Strength is scored by study design, sample size, study type, and outcomes

Overall: Moderate Evidence

Benign Prostatic Hyperplasia (BPH)

Moderate
3 studies 3 of 3 positive 200 participants 1 human

Cholesterol Management

Weak
1 study 1 of 1 positive 0 participants 0 human

Immune Modulation & Anti-inflammatory Activity

Weak
1 study 0 of 1 positive 0 participants 0 human

Clinical trials

Moderate
5 studies 0 of 5 positive 0 participants

Systematic reviews

Weak
4 studies 0 of 4 positive 0 participants 0 human

Research Visualised

Visual breakdown of the clinical data.

Study Quality Breakdown

What types of studies were conducted

5/14
Randomised
6/14
Double-Blind
6/14
Placebo-Controlled

Participants Per Study

Larger samples = more reliable results

Study 1 (1997)
200
Study 2 (2000)
0
Study 3 (2024)
0
Study 1 (2000)
0
Study 1 (2024)
0
Study 1 (2025)
0
Study 2 (2025)
0
Study 3 (2023)
0

Research Timeline

When the studies were published

1
1997
2
2000
1
2022
1
2023
5
2024
4
2025

All Studies

Detailed breakdown of each trial. Click to expand.

Benign Prostatic Hyperplasia (BPH)

1

To assess the efficacy of beta-sitosterol in the treatment of BPH.

1997 200 participants 6 months 20 mg beta-sitosterol three times daily (60 mg/day)
Human Study Double-Blind Placebo Positive

Study Type

Multicentric, placebo-controlled, double-blind

Purpose

To assess the efficacy of beta-sitosterol in the treatment of BPH.

Dose

20 mg beta-sitosterol three times daily (60 mg/day)

Participants

200 men with symptomatic BPH

Duration

6 months

Results

Beta-sitosterol significantly reduced Boyarsky symptom score and IPSS vs placebo. Peak urine flow increased significantly. Residual urine volume decreased. Beta-sitosterol is an effective option for BPH treatment.

How They Measured It

Modified Boyarsky symptom score, IPSS, peak urinary flow rate, residual volume

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2

To evaluate the evidence for beta-sitosterols in BPH treatment.

2000 ? participants 4–26 weeks Various (20-130 mg/day)
Review/Other Positive

Study Type

Cochrane systematic review

Purpose

To evaluate the evidence for beta-sitosterols in BPH treatment.

Dose

Various (20-130 mg/day)

Participants

Cochrane review across eligible RCTs

Duration

4–26 weeks

Results

Beta-sitosterol significantly improved urinary symptom scores and urinary flow. Patients were twice as likely to report improvement vs placebo. Long-term durability requires further study.

How They Measured It

Urologic symptom scales, urinary flow, residual urine, quality of life

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3

To review the evidence for beta-sitosterol for BPH treatment and prostate cancer.

2024 ? participants Various Various
Review/Other Positive

Study Type

Systematic review

Purpose

To review the evidence for beta-sitosterol for BPH treatment and prostate cancer.

Dose

Various

Participants

Review

Duration

Various

Results

Beta-sitosterol inhibits 5-alpha-reductase, modulates intraprostatic cholesterol, and reduces inflammatory mediators. Four RCTs showed significant improvement in urinary symptoms and flow in BPH patients.

How They Measured It

Review of urological outcomes, prostate cancer markers, and mechanistic data

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Cholesterol Management

1

To assess the cholesterol-lowering effects of plant sterols including beta-sitosterol.

2000 ? participants Various Various (1-3 g/day plant sterols)
Review/Other Positive

Study Type

Systematic review

Purpose

To assess the cholesterol-lowering effects of plant sterols including beta-sitosterol.

Dose

Various (1-3 g/day plant sterols)

Participants

Meta-analysis across multiple RCTs

Duration

Various

Results

Beta-sitosterol and related plant sterols significantly reduced LDL-cholesterol by 8-15%. Effects were dose-dependent and well tolerated. Plant sterols are widely recommended as dietary adjuncts for LDL management.

How They Measured It

LDL-cholesterol, total cholesterol, HDL-cholesterol

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Immune Modulation & Anti-inflammatory Activity

1

To review immunomodulatory and anti-inflammatory effects of beta-sitosterol.

2024 ? participants Various Various
Review/Other Mixed

Study Type

Mechanistic review

Purpose

To review immunomodulatory and anti-inflammatory effects of beta-sitosterol.

Dose

Various

Participants

Review

Duration

Various

Results

Beta-sitosterol modulates T-lymphocyte proliferation, enhances NK cell activity, and reduces pro-inflammatory cytokines (IL-6, TNF-α). Anti-inflammatory effects mediated via PGE2 inhibition and NF-κB modulation.

How They Measured It

Review of in vitro and in vivo immune function studies

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Clinical trials

1

To investigate the effects of Beta-Sitosterol in effects of pemafibrate on cholesterol synthesis and absorption: a post-hoc subgroup analysis of a phase 2 clinical trial.

2025 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomized, double-blind, placebo-controlled

Purpose

To investigate the effects of Beta-Sitosterol in effects of pemafibrate on cholesterol synthesis and absorption: a post-hoc subgroup analysis of a phase 2 clinical trial.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

ently, we reported that a pemafibrate extended-release (XR) formulation lowered low-density lipoprotein cholesterol (LDL-C) and cholesterol synthesis and absorption markers in a phase 2 clinical pharmacology study. Here we describe our post-hoc analysis of that study, discuss the mechanism by which pemafibrate lowers LDL-C, and suggest which patients may respond favorably to pemafibrate treatment.

How They Measured It

See study for outcome measures

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2

To investigate the effects of Beta-Sitosterol in effects of pemafibrate on ldl-c and related lipid markers in patients with masld: a sub-analysis of the pema-fl study.

2025 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Human Study RCT Double-Blind Placebo Positive

Study Type

Randomized, double-blind, placebo-controlled

Purpose

To investigate the effects of Beta-Sitosterol in effects of pemafibrate on ldl-c and related lipid markers in patients with masld: a sub-analysis of the pema-fl study.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

In the PEMA-FL study in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), pemafibrate was shown to significantly decrease low-density lipoprotein cholesterol (LDL-C) levels. We aimed to investigate the mechanisms of pemafibrate-induced LDL-C reduction in patients with MASLD by conducting an additional sub-analysis of the PEMA-FL study.

How They Measured It

See study for outcome measures

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3

To investigate the effects of Beta-Sitosterol in efficacy and safety of pitavastatin/ezetimibe fixed-dose combination vs. pitavastatin: phase iii, double-blind, randomized controlled trial.

2023 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomized, double-blind, placebo-controlled

Purpose

To investigate the effects of Beta-Sitosterol in efficacy and safety of pitavastatin/ezetimibe fixed-dose combination vs. pitavastatin: phase iii, double-blind, randomized controlled trial.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

We compared the efficacy and safety of pitavastatin/ezetimibe fixed-dose combination with those of pitavastatin monotherapy in patients with hypercholesterolemia.

How They Measured It

See study for outcome measures

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4

To investigate the effects of Beta-Sitosterol in [jianpi zishen granule inhibits podocyte autophagy in systemic lupus erythematosus: a network pharmacology and clinical study].

2024 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomized, double-blind, placebo-controlled

Purpose

To investigate the effects of Beta-Sitosterol in [jianpi zishen granule inhibits podocyte autophagy in systemic lupus erythematosus: a network pharmacology and clinical study].

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

To explore the therapeutic mechanism of Jianpi Zishen (JPZS) granules for systemic lupus erythematosus(SLE) in light of podocyte autophagy regulation.

How They Measured It

See study for outcome measures

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5

To investigate the effects of Beta-Sitosterol in a randomized controlled clinical trial examining the effects of cordyceps militaris beverage on the immune response in healthy adults.

2024 ? participants 4 weeks Beta-Sitosterol (dose not specified)
Human Study RCT Double-Blind Placebo Mixed

Study Type

Randomized, double-blind, placebo-controlled

Purpose

To investigate the effects of Beta-Sitosterol in a randomized controlled clinical trial examining the effects of cordyceps militaris beverage on the immune response in healthy adults.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

4 weeks

Results

x3b2; levels were markedly reduced in the male FCM group (p = 0.049). Furthermore, the IL-6 levels decreased from baseline in the female FCM group (p = 0.047). The blood sugar, lipid, and safety indices were not different between the experimental groups. FCM can potentially be developed as an immune-boosting supplement without liver, kidney, or blood component toxicity.

How They Measured It

See study for outcome measures

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Systematic reviews

1

To investigate the effects of Beta-Sitosterol in evidence and characteristics of traditional chinese medicine for coronary heart disease patients with anxiety or depression: a meta-analysis and syste

2022 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Review/Other Mixed

Study Type

Systematic review and meta-analysis

Purpose

To investigate the effects of Beta-Sitosterol in evidence and characteristics of traditional chinese medicine for coronary heart disease patients with anxiety or depression: a meta-analysis and syste

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

CHM exhibited an obvious efficacy in treating CHD patients with anxiety or depression, especially for improving the symptom of angina pectoris. The most active compounds of CHM could simultaneously act on the pathological targets of CHD, anxiety, and depression. Multiple effective components and multiple targets were the advantages of CHM compared with WM.

How They Measured It

See study for outcome measures

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2

To investigate the effects of Beta-Sitosterol in integrated meta-analysis and network pharmacology analysis: evaluation of zhigancao decoction as treatment for diabetic cardiomyopathy.

2025 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Review/Other Mixed

Study Type

Systematic review and meta-analysis

Purpose

To investigate the effects of Beta-Sitosterol in integrated meta-analysis and network pharmacology analysis: evaluation of zhigancao decoction as treatment for diabetic cardiomyopathy.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

variety of cardiovascular conditions. As of now, there are no data to support its use as a treatment for diabetic cardiomyopathy (DCM) and the mechanism behind the effect is unclear as well. In the present study, clinical evidence for the efficacy of ZGCD in patients with DCM was examined using a meta-analysis and its underlying anti-DCM molecular mechanisms were explored via network pharmacology.

How They Measured It

See study for outcome measures

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3

To investigate the effects of Beta-Sitosterol in efficacy and mechanism of qianjinweijing decoction for asthma: integrating systematic review with meta-analysis and network pharmacology.

2025 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Review/Other Mixed

Study Type

Systematic review and meta-analysis

Purpose

To investigate the effects of Beta-Sitosterol in efficacy and mechanism of qianjinweijing decoction for asthma: integrating systematic review with meta-analysis and network pharmacology.

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

y. Modern clinical use of Qianjinweijing Decoction (QJWJ) for the treatment of asthma has achieved good results. However, there is still a lack of research on its efficacy and mechanism of action. Therefore, the purpose of this study is to evaluate the efficacy of QJWJ in the treatment of asthma by systematic review and meta-analysis, and to explore its potential mechanism by network pharmacology.

How They Measured It

See study for outcome measures

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4

To investigate the effects of Beta-Sitosterol in exploration of the mechanism of traditional chinese medicine for anxiety and depression in patients with diarrheal irritable bowel syndrome based on n

2024 ? participants Duration not specified Beta-Sitosterol (dose not specified)
Review/Other Mixed

Study Type

Systematic review and meta-analysis

Purpose

To investigate the effects of Beta-Sitosterol in exploration of the mechanism of traditional chinese medicine for anxiety and depression in patients with diarrheal irritable bowel syndrome based on n

Dose

Beta-Sitosterol (dose not specified)

Participants

Participants not specified

Duration

Duration not specified

Results

The efficacy of Chinese herbal medicine (CHM) in managing irritable bowel syndrome with diarrhea (IBS-D) accompanied by anxiety and depression remains uncertain. Thus, a systematic review was carried out employing meta-analysis and network pharmacology to ascertain the efficacy and underlying mechanisms of CHM therapy.

How They Measured It

See study for outcome measures

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Frequently Asked Questions

Common questions about Beta-Sitosterol research

What does the research say about Beta-Sitosterol?

There are currently 14 peer-reviewed studies on Beta-Sitosterol (β-Sitosterol (Plant Phytosterol)), involving 200 total participants. Research covers Benign Prostatic Hyperplasia (BPH), Cholesterol Management, Immune Modulation & Anti-inflammatory Activity and 2 more areas. The overall evidence strength is rated as Moderate.

How strong is the evidence for Beta-Sitosterol?

The evidence is currently rated as "Moderate Evidence". This rating is based on study design quality (randomisation, blinding, placebo controls), sample sizes, study types (6 human studies), and reported outcomes.

What health goals has Beta-Sitosterol been studied for?

Beta-Sitosterol has been researched for: Benign Prostatic Hyperplasia (BPH), Cholesterol Management, Immune Modulation & Anti-inflammatory Activity, Clinical trials, Systematic reviews. Each area has its own body of evidence which you can explore in the study breakdowns above.

Are the studies on Beta-Sitosterol based on human trials?

Yes, 6 out of 14 studies are human trials. Human trials carry more weight in our evidence scoring system.