Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 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 Actiponin as a novel anti-obesity agent. However, the efficacy and safety of Actiponin supplementation on body weight regulation in humans are lacking.
详细描述
The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on body weight and fat loss along with changes in metabolic markers based on 12 week, randomized, double-blind, placebo-controlled clinical trial.
Eighty obesity subjects with BMI > 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group (n=40, 450mg/day) for 12weeks.
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
- •BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)
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 theire absorption, such as gastrointestinal disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •Abdominal hepatic liver function
- •Renal disease, e.g. acute/chronic renal failure, nephritic syndrome
- •Used antipsychosis drugs therapy 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
- •History of alcohol or substance abuse
- •Allergic or hypersensitive to any of the ingredients in the test products
结局指标
主要结局
Changes in Body Fat Mass.
时间窗: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
次要结局
- Changes in Body Weight.(study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week))
- Changes in Abdominal Total Fat Area.(study visit 1(0 week), visit 4(12 week))
- Changes in Body Mss Index(BMI)(study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week))
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital