Body FatNCT06609603
Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex
A study testing HTGT compound in people with Body Fat, run by Amorepacific Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat
- What is being tested?
- HTGT compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
- 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
Trial locations and contacts
1 site in 1 country.
HyunJin Nam, Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Catholic University St. Vincent Hospital
Suwon, Gyeonggi-do
Sang-Wook Song, M.D./Ph.D., 82-31-881-8859, fmssw@catholic.ac.kr
About this study
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
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
Read the 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.
- Conditions
- Body Fat
- Being tested
- HTGT compound, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTGT compoundDietary supplement
oral administration of HTGT compound once daily
PlaceboDietary supplement
Oral administration of placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: HTGT compound |
| Placebo | Placebo comparator | Once daily, 2 capsules per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body fat by DEXA
Measurement was made by using dual-energy X-ray absorption(DEXA)
Measured: Baseline, Week 12
Secondary outcomes (4)
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area
Measurement of the target area is made using computed tomography
Measured: Baseline, Week 12
Changes of indicator of lipid metabolism
indicator of lipid metabolism (i.e., TC, TG, HDL, LDL)
Measured: Baseline, Week 12
Changes of waist circumference
Measurement of waist circumfernece was performed in accordance with WHO guideline
Measured: Baseline, Week 12
Changes of blood biomarker
adiponectin, etc.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start17 Nov 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-Wook Song, M.D./Ph.D, Principal investigator, Catholic University St. Vincent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609603
- Sponsor's protocol ID
- AP-PV-2023-01
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06609603
- Acronym / sponsor ID
- AP-PV-2023-01
- Conditions
- Body Fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTGT compound | Experimental | Dietary Supplement: HTGT compound* 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 comparator | Dietary Supplement: PlaceboOnce daily, 2 capsules per day |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTGT compoundoral administration of HTGT compound once daily | Dietary supplement | HTGT compound |
| PlaceboOral administration of placebo once daily | Dietary supplement | Placebo |
Primary outcome
Change of body fat by DEXA
Time frame: Baseline, Week 12
Measurement was made by using dual-energy X-ray absorption(DEXA)
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HyunJin Nam, Ph.D. contact
Sang-Wook Song, M.D./Ph.D principal investigator
Catholic University St. Vincent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTGT compound in people with Body Fat, run by Amorepacific Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonghee Sohn (800-555-5555, sohnjh@amorepacific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body fat by DEXA (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.