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