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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT00945737
First received: July 21, 2009
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Hypercholesterolemia
 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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

  Eligibility

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

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

Locations
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
Investigators
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:
hypercholesterolemia
cholesterol
soy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013