Effects of Green Tea on Body Weight Reduction and Gut Microbiota
- Conditions
- Obesity
- Interventions
- Dietary Supplement: Green tea
- Registration Number
- NCT03537625
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age 20-60 years
- BMI 25-35 kg/m2
- Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Green tea Placebo Fermented green tea Green tea Fermented green tea extract 2 gram per day Green tea Green tea Green tea extract 2 gram per day
- Primary Outcome Measures
Name Time Method Body weight Baseline, and 12 weeks Body weight change were calculated using electronic scale
Body fat Baseline, and 12 weeks Total body fat change were calculated using DXA and abdominal fat CT
- Secondary Outcome Measures
Name Time Method Lipid profile Baseline, and 12 weeks total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1
Microbiota Baseline, and 12 weeks Gut Microbiota composition
Waist circumference Baseline, 6 weeks, and 12 weeks Waist circumference was measured using standard method
Inflammatory markers Baseline, and 12 weeks hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6)