Status:
RECRUITING
Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex
Lead Sponsor:
Amorepacific Corporation
Conditions:
Body Fat
Eligibility:
All Genders
19-64 years
Phase:
NA
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 i...
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
Exclusion
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06609603
Start Date
November 17 2023
End Date
June 30 2025
Last Update
September 24 2024
Active Locations (1)
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1
Catholic University St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea