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

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ClinicalTrials.gov Identifier: NCT00945737
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Solae, LLC

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.

Condition or disease Intervention/treatment
Hypercholesterolemia Dietary Supplement: Soy protein; 25 grams/day Dietary Supplement: Control protein

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Soy protein Dietary Supplement: Soy protein; 25 grams/day
Soy protein
Placebo Comparator: Milk protein Dietary Supplement: Control protein
Milk protein

Primary Outcome Measures :
  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 Outcome Measures :
  1. Changes in other lipid levels and other related biomarkers [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Solae, LLC:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases