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| Name | Class |
|---|---|
| Amorepacific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green tea | Experimental | Green tea extract 2 gram per day |
|
| Fermented green tea | Experimental | Fermented green tea extract 2 gram per day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea | Dietary Supplement | We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |