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

Completed · Not applicable

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00945737

Run by

Solae, LLC

People needed

60

Starts

2009-04-01

Expected to finish

2009-08-01

Last updated by the study team

2012-06-07

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Provident Clinical Research — Addison, Illinois, United States
• Provident Clinical Research — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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