NCT00825838已完成2 期
A Randomized Double-Blind Placebo-Controlled Clinical Trial of a Purified Chili Pepper Extract (CH-19 Sweet Extract) to Evaluate Its Safety and Efficacy for Weight and Fat Loss and Metabolism Change in Overweight or Obese Healthy Male and Female Adults
Ajinomoto USA, INC.0 个研究点目标入组 80 人开始时间: 2006年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- body weight and body composition
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is overweight or obese but otherwise generally healthy who interested in losing weight
- •BMI of 25 to 35 kg/m2
- •Waist/hip ratio of 0.9 or more for male and 0.85 for female.
排除标准
- •Type 1 or 2 diabetes mellitus
- •cardiovascular disease (other than mild, controlled hypertension or dislidemia)
- •On a weight-loss program within six months
结局指标
主要结局
body weight and body composition
时间窗: 12 weeks
次要结局
- resting metabolic rate and substrate oxidation(12 weeks)
研究者
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