Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGreen tea
We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.
Sponsors
Amorepacific Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline, 6 weeks, and 12 weeks | Waist circumference was measured using standard method |
| Lipid profile | Baseline, and 12 weeks | total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1 |
| Inflammatory markers | Baseline, and 12 weeks | hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6) |
| Microbiota | Baseline, and 12 weeks | Gut Microbiota composition |
Outcome results
None listed