Effects of Green Tea on Body Weight Reduction and Gut Microbiota

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Green tea

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2016
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SNUBH-GT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No