Status:
COMPLETED
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
Lead Sponsor:
Solae, LLC
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-79 years
Phase:
NA
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) concentrati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00945737
Start Date
April 1 2009
End Date
August 1 2009
Last Update
June 7 2012
Active Locations (2)
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1
Provident Clinical Research
Addison, Illinois, United States, 60101
2
Provident Clinical Research
Bloomington, Indiana, United States, 47403