NCT02108691已完成2 期
Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in Body Fat Mass
研究概览
简要总结
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-65 years old
- •BMI(body mass index) ≥ 25 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
- •Able to give informed consent
排除标准
- •Significant variation in weight(more 10%) in the past 3 months
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
结局指标
主要结局
Changes in Body Fat Mass
时间窗: 8 weeks
Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).
次要结局
- Changes in Percent Body Fat(8 weeks)
- Changes in Weight(8 weeks)
- Changes in BMI(Body Mass Index)(8 weeks)
- Changes in LDLc(8 weeks)
- Changes in Non-HDLc(8 weeks)
- Changes in LDLc/HDLc(8 weeks)
研究者
Yongsoon Park
Associate Professor
Hanyang University
研究点 (2)
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