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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Control protein; Dietary Supplement: Soy protein; 25 grams/day

• Registration Number: NCT00945737
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk protein	Control protein	-
Soy protein	Soy protein; 25 grams/day	-

Primary Outcome Measures

Name	Time	Method
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C	4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in other lipid levels and other related biomarkers	4 weeks

Trial Locations

Locations (1)

Provident Clinical Research; 🇺🇸 Bloomington, Indiana, United States