Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change from baseline body weight at week 8
研究概览
简要总结
The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.
详细描述
This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •aged 20-60 years old
- •body mass index is greater than or equal to 24 kg/m2, or body fat more than 30%
排除标准
- •Subjects diagnosed with cancer and on curative care.
- •Subjects diagnosed with heart disease and on curative care.
- •Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
- •Subjects with systemic infection requiring antibiotics.
结局指标
主要结局
Change from baseline body weight at week 8
时间窗: Week 0, Week 8
Compared the difference of body weight between the week 8 and 0.
次要结局
- Change from baseline body fat at week 8(Week 0, Week 8)
研究者
Chin-Lin Hsu
Professor
Chung Shan Medical University