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
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2023
CompletedFirst Submitted
Initial submission to the registry
September 10, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedSeptember 24, 2024
September 1, 2024
1.5 years
September 10, 2024
September 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of body fat by DEXA
Measurement was made by using dual-energy X-ray absorption(DEXA)
Baseline, Week 12
Secondary Outcomes (4)
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area
Baseline, Week 12
Changes of indicator of lipid metabolism
Baseline, Week 12
Changes of waist circumference
Baseline, Week 12
Changes of blood biomarker
Baseline, Week 12
Study Arms (2)
HTGT compound
EXPERIMENTAL* Dietary supplement: HTGT compound * oral administration of HTGT compound once daily, 2 capsules per day. * Dietary supplement; Placebo * oral administration of placebo once daily, 2 canpules per day
Placebo
PLACEBO COMPARATOROnce daily, 2 capsules per day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Wook Song, M.D./Ph.D
Catholic University St. Vincent Hospital
Central Study Contacts
HyunJin Nam, Ph.D.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2024
First Posted
September 24, 2024
Study Start
November 17, 2023
Primary Completion
May 30, 2025
Study Completion
June 30, 2025
Last Updated
September 24, 2024
Record last verified: 2024-09