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Completed

NCT Number: NCT03537625

Effects of Green Tea on Body Weight Reduction and Gut Microbiota

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea

Dietary Supplement

We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.

Primary outcomes

  1. Body weight

    Time frame: Baseline, and 12 weeks

    Body weight change were calculated using electronic scale

  2. Body fat

    Time frame: Baseline, and 12 weeks

    Total body fat change were calculated using DXA and abdominal fat CT

Secondary outcomes

  1. Waist circumference

    Time frame: Baseline, 6 weeks, and 12 weeks

    Waist circumference was measured using standard method

  2. Lipid profile

    Time frame: Baseline, and 12 weeks

    total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1

  3. Inflammatory markers

    Time frame: Baseline, and 12 weeks

    hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6)

  4. Microbiota

    Time frame: Baseline, and 12 weeks

    Gut Microbiota composition

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Amorepacific Corporation

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 25, 2018
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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