A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex

Amorepacific Corporation1 site in 1 country100 target enrollmentNovember 17, 2023

ConditionsBody Fat

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Body Fat
Sponsor: Amorepacific Corporation
Enrollment: 100
Locations: 1
Primary Endpoint: Change of body fat by DEXA
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

November 17, 2023

End Date

June 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amorepacific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change of body fat by DEXA

Time Frame: Baseline, Week 12

Measurement was made by using dual-energy X-ray absorption(DEXA)

Secondary Outcomes

Changes of total abdominal fat area, visceral fat area and subcutaneous fat area(Baseline, Week 12)
Changes of indicator of lipid metabolism(Baseline, Week 12)
Changes of waist circumference(Baseline, Week 12)
Changes of blood biomarker(Baseline, Week 12)