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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.
Body weight
Body weight change were calculated using electronic scale
Time frame: Baseline, and 12 weeks
Body fat
Total body fat change were calculated using DXA and abdominal fat CT
Time frame: Baseline, and 12 weeks
Waist circumference
Waist circumference was measured using standard method
Time frame: 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
Time frame: Baseline, and 12 weeks
Inflammatory markers
hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6)
Time frame: Baseline, and 12 weeks
Microbiota
Gut Microbiota composition
Time frame: Baseline, and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.