NCT00880646已完成不适用
Effects of the Combination of L-Arabinose and Indigestible Dextrin 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
- 70
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, 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
- All
- 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
- •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: 20 weeks
次要结局
- Body fat mass(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin and leptin levels(Week 0, Week 12)
- Abdominal circumference(Every 4 weeks (Overall 20 weeks))
- Visceral fat area by CT scan(Week 0, Week 12)
- Frequency of bowel movement(20 weeks)
- Serum lipid profile(Every 4 weeks (Overall 20 weeks))
- Fasting serum glucose and HbA1c levels(Every 4 weeks (Overall 20 weeks))
研究者
研究点 (2)
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