Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex

NCT ID: NCT06609603

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Body Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HTGT compound

Intervention Type DIETARY_SUPPLEMENT

oral administration of HTGT compound once daily

Placebo

Once daily, 2 capsules per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Oral administration of placebo once daily

Interventions

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HTGT compound

oral administration of HTGT compound once daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral administration of placebo once daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amorepacific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-Wook Song, M.D./Ph.D

Role: PRINCIPAL_INVESTIGATOR

Catholic University St. Vincent Hospital

Locations

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Catholic University St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jonghee Sohn

Role: CONTACT

800-555-5555

HyunJin Nam, Ph.D.

Role: CONTACT

Facility Contacts

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Sang-Wook Song, M.D./Ph.D.

Role: primary

82-31-881-8859

Other Identifiers

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AP-PV-2023-01

Identifier Type: -

Identifier Source: org_study_id

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