Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HTGT compound, Placebo.
- Who it may be relevant to
- Registry conditions: Body Fat. Basic parameters: 19 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex
Overview
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 supplement HTGT compound
oral administration of HTGT compound once daily - Dietary supplement Placebo
Oral administration of placebo once daily
Primary outcome measures
- Change of body fat by DEXA [Time frame: Baseline, Week 12]
Secondary outcome measures (4)
- Changes of total abdominal fat area, visceral fat area and subcutaneous fat area [Time frame: Baseline, Week 12]
- Changes of indicator of lipid metabolism [Time frame: Baseline, Week 12]
- Changes of waist circumference [Time frame: Baseline, Week 12]
- Changes of blood biomarker [Time frame: Baseline, Week 12]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Catholic University St. Vincent Hospital — Suwon
Identifiers
NCT: NCT06609603 · AP-PV-2023-01