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

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

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.

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