Evaluating the effects of heat-treated green tea extract on body fat reduction
A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex
NA · Amorepacific Corporation · NCT06609603
This study is testing if a special green tea extract can help obese adults lose body fat over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | Amorepacific Corporation (industry) |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06609603 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the efficacy and safety of a heat-treated green tea extract complex in reducing body fat among obese adults. It is a 12-week, randomized, double-blind, placebo-controlled trial involving 100 participants who will be assigned to either the treatment group receiving the extract or a placebo group. Participants will take two capsules of the heat-treated green tea extract daily for the duration of the study, with changes in body fat evaluated as the primary endpoint.
Who should consider this trial
Good fit: Ideal candidates for this study are obese adults aged 19 to 64 with a BMI between 25.0 and 34.9 kg/m².
Not a fit: Patients who have undergone recent weight loss interventions or have uncontrolled health conditions such as diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective natural supplement for weight management in obese individuals.
How similar studies have performed: Other studies have shown promising results with green tea extracts for weight management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Suwon, Gyeonggi-do
- Catholic University St. Vincent Hospital — Suwon, Gyeonggi-do, South Korea (RECRUITING)
Study contacts
- Principal investigator: Sang-Wook Song, M.D./Ph.D — Catholic University St. Vincent Hospital
- Study coordinator: Jonghee Sohn
- Email: sohnjh@amorepacific.com
- Phone: 800-555-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Body Fat