A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia (PRV-08009)

This study has been completed.
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
First received: July 21, 2009
Last updated: June 6, 2012
Last verified: June 2012

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.

Condition Intervention
Dietary Supplement: Soy protein; 25 grams/day
Dietary Supplement: Control protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:

Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in other lipid levels and other related biomarkers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy protein Dietary Supplement: Soy protein; 25 grams/day
Soy protein
Placebo Comparator: Milk protein Dietary Supplement: Control protein
Milk protein


Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945737

United States, Illinois
Provident Clinical Research
Addison, Illinois, United States, 60101
United States, Indiana
Provident Clinical Research
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Solae, LLC
Principal Investigator: Matthew Reeves, DO Provident Clinical Research
Principal Investigator: Mano Patri, MD Provident Clinical Research, Addison, IL
  More Information

No publications provided by Solae, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT00945737     History of Changes
Other Study ID Numbers: PRV-08009
Study First Received: July 21, 2009
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Solae, LLC:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014