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

Not Applicable

Recruiting

• Conditions: Body Fat
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: HTGT compound

• Registration Number: NCT06609603
• Lead Sponsor: Amorepacific Corporation

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.

Study Timeline

• Study Start: 2023-11-17
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once daily, 2 capsules per day
HTGT compound	HTGT compound	* Dietary supplement: HTGT compound * oral administration of HTGT compound once daily, 2 capsules per day. * Dietary supplement; Placebo * oral administration of placebo once daily, 2 canpules per day

Primary Outcome Measures

Name	Time	Method
Change of body fat by DEXA	Baseline, Week 12	Measurement was made by using dual-energy X-ray absorption(DEXA)

Secondary Outcome Measures

Name	Time	Method
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area	Baseline, Week 12	Measurement of the target area is made using computed tomography
Changes of indicator of lipid metabolism	Baseline, Week 12	indicator of lipid metabolism (i.e., TC, TG, HDL, LDL)
Changes of waist circumference	Baseline, Week 12	Measurement of waist circumfernece was performed in accordance with WHO guideline
Changes of blood biomarker	Baseline, Week 12	adiponectin, etc.

Trial Locations

Locations (1)

Catholic University St. Vincent Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of