A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of body fat mass
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.
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
- •age between 19 and 65 years,
- •BMI 25~29.9 kg/m2
- •subjects giving written informed consent
排除标准
- •Significant variation in weight(more 10%) in the past 3 months
- •Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
- •History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- •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
- •Pregnancy or breast feeding etc,.
研究组 & 干预措施
Zingiber officinale Roscoe extract 200 mg
2 cap/day, 800 mg/cap for 12 weeks
干预措施: Zingiber officinale Roscoe extract 200 mg (Dietary Supplement)
Placebo
Placebo for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes of body fat mass
时间窗: Baseline and 12 week
Body fat mass was measured in study baseline and 12 week
次要结局
- Changes of percent body fat(Baseline and 12 week)
- Changes of fat free mass(Baseline and 12 week)
- Changes of weight(Baseline and 12 week)
- Changes of body mass index(Baseline and 12 week)
研究者
Soo-Wan Chae
Principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital