A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia (PRV-08009)

Solae, LLC

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Control protein; Dietary Supplement: Soy protein; 25 grams/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945737

PRV-08009

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Soy protein

Active Comparator group

Treatment:

Dietary Supplement: Soy protein; 25 grams/day

Milk protein

Placebo Comparator group

Treatment:

Dietary Supplement: Control protein