Effects of Green Tea on Body Weight Reduction and Gut Microbiota

Seoul National University

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Green tea

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03537625

SNUBH-GT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Green tea

Experimental group

Description:

Green tea extract 2 gram per day

Treatment:

Dietary Supplement: Green tea

Fermented green tea

Experimental group

Description:

Fermented green tea extract 2 gram per day

Treatment:

Dietary Supplement: Green tea

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Green tea