A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945737

Acronym

PRV-08009

Enrollment

Registered

2009-07-24

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia, cholesterol, soy

Brief summary

The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.

Interventions

DIETARY_SUPPLEMENTSoy protein; 25 grams/day

Soy protein

DIETARY_SUPPLEMENTControl protein

Milk protein

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Male or female * 18-79 years of age * Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications * otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.

Exclusion criteria

* CHD or CHD risk equivalent * Pregnancy * Food allergy or sensitivity to soy or milk protein * Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications * Poorly controlled hypertension * Cancer treated within prior 2 years

Design outcomes

Primary

Measure	Time frame
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C	4 weeks

Secondary

Measure	Time frame
Changes in other lipid levels and other related biomarkers	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026