Effects of Green Tea on Body Weight Reduction and Gut Microbiota

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537625
• Other study ID #: SNUBH-GT
• Status: Completed
• Phase: N/A
• Start date: March 20, 2016
• Est. completion date: April 13, 2018

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Green tea
We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Amorepacific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight change were calculated using electronic scale	Baseline, and 12 weeks
Primary	Body fat	Total body fat change were calculated using DXA and abdominal fat CT	Baseline, and 12 weeks
Secondary	Waist circumference	Waist circumference was measured using standard method	Baseline, 6 weeks, and 12 weeks
Secondary	Lipid profile	total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1	Baseline, and 12 weeks
Secondary	Inflammatory markers	hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1ß, IL-6)	Baseline, and 12 weeks
Secondary	Microbiota	Gut Microbiota composition	Baseline, and 12 weeks