NCT00945737已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Solae, LLC
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Soy protein
Active Comparator
干预措施: Soy protein; 25 grams/day (Dietary Supplement)
Milk protein
Placebo Comparator
干预措施: Control protein (Dietary Supplement)
结局指标
主要结局
The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
时间窗: 4 weeks
次要结局
- Changes in other lipid levels and other related biomarkers(4 weeks)
研究者
研究点 (2)
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