Efficacy and Safety of Fermented Cinnamon Vine Powder on Decrement of Body Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in abdominal Fat
研究概览
简要总结
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of body fat. The investigators measured decrement of body fat parameters , including abdominal fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-55 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.
研究组 & 干预措施
Fermented Cinnamon Vine Powder
干预措施: Fermented Cinnamon Vine Powder (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in abdominal Fat
时间窗: 12 weeks
Abdominal Fat was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Body Fat Mass
时间窗: 12 weeks
Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)(12 weeks)
- Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)(12 weeks)
- Changes in total cholesterol(12 weeks)
- Changes in Triglycerides(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital