Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex

Last updated: September 19, 2024
Sponsor: Amorepacific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Treatment

Placebo

HTGT compound

Clinical Study ID

NCT06609603
AP-PV-2023-01
  • Ages 19-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This clinical study was designed to evaluate the efficacy and safety of body fat reduction in obese adults by treatment of heat-treated green tea extract complex

Eligibility Criteria

Inclusion

  • lt;Inclusion Criteria>

  • Males and females aged between 19 ~ 64 years

  • BMI 25.0 ~ 34.9 kg/m^2

  • Waist circumferebce: 90cm or more for men, 85cm or more for women

  • Subjects who have fully understand the information provided about the study and voluntarily decided to participate

  • lt;Exclusion Criteria>

  • Participants whose weight changed by more than 10% within the 3 months prior to visit 1

  • Individuals participated in a commercial weight loss program within 3 months prior to Visit 1

  • Participants who have undergone surgical procedures within 3 years

  • Participants who have taken obesity treatment medications within the last 3 months

  • Individuals who have taken medications affecting weight or dietary supplements for weight control within the last month

  • Subjects with uncontrolled hypertension

  • Subjects diagnosed with diabetes

  • TSH <0.1 uIU/ml or >10 uIU/ml

  • Creatinine >1.5mg/dL

  • AST or ALT > three times the upper normal limit

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
November 17, 2023
Estimated Completion Date:
June 30, 2025

Study Description

This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial. 100 subjects were ranromly assigned to heat-treated green tea extract(HTGT) group and placebo group. The changes in the efficacy endpoint were evaluated after treatment of 2 capsules of HTGT once daiy for 12 weeks.

Connect with a study center

  • Catholic University St. Vincent Hospital

    Suwon, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

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