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

Hypercholesterolemia Clinical Trial

— PRV-08009  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945737
• Other study ID #: PRV-08009
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: June 6, 2012
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: Solae, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Soy protein; 25 grams/day
Soy protein
• Control protein
Milk protein

Locations

Country	Name	City	State
United States	Provident Clinical Research	Addison	Illinois
United States	Provident Clinical Research	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Solae, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C		4 weeks	No
Secondary	Changes in other lipid levels and other related biomarkers		4 weeks	No