Effects of Green Tea on Body Weight Reduction and Gut Microbiota

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Green tea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-60 years BMI 25-35 kg/m2 Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green tea<br>Green tea extract 2 gram per day | Dietary Supplement: Green tea<br>* We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.<br>|
| Experimental: Fermented green tea<br>Fermented green tea extract 2 gram per day | Dietary Supplement: Green tea<br>* We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Green tea<br>* We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight change were calculated using electronic scale | Baseline, and 12 weeks | 
| Body fat | Total body fat change were calculated using DXA and abdominal fat CT | Baseline, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference was measured using standard method | Baseline, 6 weeks, and 12 weeks | 
| Lipid profile | total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1 | Baseline, and 12 weeks | 
| Inflammatory markers | hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6) | Baseline, and 12 weeks | 
| Microbiota | Gut Microbiota composition | Baseline, and 12 weeks |