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

Solae, LLC1 个研究点分布在 1 个国家目标入组 60 人2009年4月

适应症Hypercholesterolemia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Hypercholesterolemia
发起方: Solae, LLC
入组人数: 60
试验地点: 1
主要终点: The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
状态: 已完成
最后更新: 13年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2009年4月

结束日期

2009年8月

最后更新

13年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Solae, LLC

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•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