Body Fat
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHTGT compound
oral administration of HTGT compound once daily
DIETARY_SUPPLEMENTPlacebo
Oral administration of placebo once daily
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of body fat by DEXA | Baseline, Week 12 | Measurement was made by using dual-energy X-ray absorption(DEXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactJonghee Sohn
Backup ContactHyunJin Nam, Ph.D.
Outcome results
None listed