NCT02742688Unknown2 期
Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid.
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 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 Pyrus pyrifolia var. culta(Makino) NaKai 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) 25~29.9 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
- •Able to give informed consent
排除标准
- •BMI(body mass index) ≥ 30 kg/m^2
- •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 week
Body fat mass was measured in study baseline and visit 3(8 week)
次要结局
- Change in total cholesterol(8 week)
- Change in triglyceride(8 week)
- Change in body mass index(8 week)
- Changes in percent body fat(8 week)
- Change in fat free mass(8 week)
- Change in weight(8 week)
研究者
Yongsoon Park
professor
Hanyang University
研究点 (2)
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