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OpenTrials
Completed

NCT Number: NCT00945737

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provident Clinical Research, Addison, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy protein; 25 grams/day

Dietary Supplement

Soy protein

Control protein

Dietary Supplement

Milk protein

Primary outcomes

  1. The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C

    Time frame: 4 weeks

Secondary outcomes

  1. Changes in other lipid levels and other related biomarkers

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Solae, LLC

Industry

Registry information

Official study title

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

Acronym: PRV-08009

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2009
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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