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

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

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

Study Overview

• Status: Recruiting
• Conditions: Body Fat
• Intervention / Treatment: Dietary supplement: HTGT compound; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonghee Sohn; Phone Number: 800-555-5555; Email: sohnjh@amorepacific.com
• Study Contact Backup: Name: HyunJin Nam, Ph.D.

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Catholic University St. Vincent Hospital
      • Contact: Sang-Wook Song, M.D./Ph.D.; Phone Number: 82-31-881-8859; Email: fmssw@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HTGT compound; Dietary supplement: HTGT compoundoral administration of HTGT compound once daily, 2 capsules per day.; Dietary supplement; Placebooral administration of placebo once daily, 2 canpules per day	Dietary supplement: HTGT compound; oral administration of HTGT compound once daily
Placebo Comparator: Placebo; Once daily, 2 capsules per day	Dietary supplement: Placebo; Oral administration of placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body fat by DEXA	Measurement was made by using dual-energy X-ray absorption(DEXA)	Baseline, Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Principal Investigator: Sang-Wook Song, M.D./Ph.D, Catholic University St. Vincent Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AP-PV-2023-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No