NCT01778257已完成2 期
Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Changes in body and abdominal fat
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.
详细描述
The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.
Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.
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
- •Volunteers aged 19 to 65 years
- •25 kg/m2 ≤ BMI ≥35 kg/m2
- •Ability to give informed consent
排除标准
- •Significant variation in weight (more 10%) in the past 3 month
- •Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
- •History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
- •Allergic or hypersensitive to any of the ingredients in the test products
- •Pregnancy or breast feeding
- •Used antipsychosis drugs therapy within past 2 months
- •History of alcohol or substance abuse (21 units/week over)
- •Participation in any other clinical trials within past 3 months
研究组 & 干预措施
Placebo group
Placebo Comparator
Placebo (3150 mg/day) for 12 weeks
干预措施: Placebo (Dietary Supplement)
Mate extracts group
Experimental
Mate extract(3150 mg/day)for 12 weeks
干预措施: Mate extract (Dietary Supplement)
结局指标
主要结局
Changes in body and abdominal fat
时间窗: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks
次要结局
- Changes in anthropometric parameters(weight, BMI, waist and hip circumference)(baseline, 6 weeks and 12 weeks)
- Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)(baseline, 6 weeks and 12 weeks)
研究者
Min-Gul Kim, MD
Clinical Assistant Professor
Chonbuk National University Hospital
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