Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat
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
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf Extract supplementation on body weight regulation in humans are lacking.
详细描述
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Hippophae rhamnoides L. Leaf Extract on body fat. 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 or Waist circumference ≥ 90(men), ≥ 85(women),
- •subjects giving written informed consent
排除标准
- •BMI ≥ 30 kg/m2
- •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,.
结局指标
主要结局
Changes in body fat mass
时间窗: Baseline and 12 week
Body fat mass was measured in study baseline and visit 3(12 week).
次要结局
- Change in weight(Baseline and 12 week)
- Change in fat free mass(Baseline and 12 week)
- Change in body mass index(Baseline and 12 week)
- Change in percent body fat(Baseline and 12 week)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital