NCT00880958已完成不适用
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy as based on medical history and physical examination
- •BMI between 25 and 30 kg/m2
- •Willing not to serve as blood donor during the study
- •Informed consent signed
排除标准
- •Food allergy
- •Female subjects who are pregnant or nursing a child
- •Participation in any clinical trial up to 90 days before Day 01 of this study
- •Renal or hepatic dysfunction
- •Heart disease
- •Under medication
- •Subjects who are taking functional food designed for weight loss or serum lipid reduction
结局指标
主要结局
Body mass index
时间窗: 16 weeks
次要结局
- Body fat mass(Week -4, Week 0, Week 4, Week 12)
- Abdominal circumference(Week -4, Week 0, Week 4, Week 12)
- Visceral fat area by CT scan(Week 0, Week 12)
- Intestinal flora(Week 0, Week 12)
- Serum lipid profile(Week -4, Week 0, Week 4, Week 12)
- Serum adiponectin and leptin levels(Week 0, Week 12)
- Fasting serum glucose and HbA1c levels(Week -4, Week 0, Week 4, Week 12)
研究者
研究点 (2)
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