Effects of Green Tea and Fermented Green Tea Extract on Obese Adults: a Randomized Double-blind, Placebo-controlled Study Focused on Change of Gut Microbiota and Inflammatory Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Body weight
研究概览
简要总结
The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.
详细描述
After screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were supplied to each participants under double-blind conditions. The investigators obtained blood and stool samples both baseline and final visit at 12 weeks. For improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-60 years
- •BMI 25-35 kg/m2
- •Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm
排除标准
- •Cardiovascular events within 3 months
- •uncontrolled hypertension (>160/100 mmHg)
- •Diabetes mellitus
- •Dyslipidemia under statin therapy
- •TSH<0.1 uU/ml or>10 uU/ml
- •Elevated creatinine level (twice higher than upper normal limit)
- •Elevated AST/ALT level (three times higher than upper normal limit)
- •Pregnancy, lactation
研究组 & 干预措施
Green tea
Green tea extract 2 gram per day
干预措施: Green tea (Dietary Supplement)
Placebo
Placebo
干预措施: Green tea (Dietary Supplement)
Fermented green tea
Fermented green tea extract 2 gram per day
干预措施: Green tea (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: Baseline, and 12 weeks
Body weight change were calculated using electronic scale
Body fat
时间窗: Baseline, and 12 weeks
Total body fat change were calculated using DXA and abdominal fat CT
次要结局
- Lipid profile(Baseline, and 12 weeks)
- Microbiota(Baseline, and 12 weeks)
- Waist circumference(Baseline, 6 weeks, and 12 weeks)
- Inflammatory markers(Baseline, and 12 weeks)