Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline body weight at week 12
研究概览
简要总结
The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.
详细描述
This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 20-50 years old
- •body mass index is greater than or equal to 27 kg/m2
- •waist greater than or equal to 80 cm
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 12
时间窗: Week 0, Week 12
Compared the difference of body weight between the week 12 and 0.
Change from baseline body fat at week 12
时间窗: Week 0, Week 12
Compared the difference of body fat between the week 12 and 0.
次要结局
未报告次要终点
研究者
Chin-Lin Hsu
Professor
Chung Shan Medical University