Clinical Study to Evaluate the Body Fat Reducing Effects... | NCT06609603

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

NCT06609603

Sponsor

Amorepacific Corporation

Status

Recruiting

Last Update Posted

Sep 24, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Body Fat

Interventions

HTGT compound
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2023Actual

Primary Completion Date

May 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Sep 19, 2024

First Posted Date

Sep 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Dietary Supplement: HTGT compound
Placebo	Placebo Comparator	Once daily, 2 capsules per day	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HTGT compound	Dietary Supplement	oral administration of HTGT compound once daily	HTGT compound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of body fat by DEXA	Measurement was made by using dual-energy X-ray absorption(DEXA)	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area	Measurement of the target area is made using computed tomography	Baseline, Week 12
Changes of indicator of lipid metabolism

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonghee Sohn	Contact	800-555-5555		sohnjh@amorepacific.com
HyunJin Nam, Ph.D.	Contact

Overall Officials

Name	Affiliation	Role
Sang-Wook Song, M.D./Ph.D	Catholic University St. Vincent Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University St. Vincent Hospital	Recruiting	Suwon	Gyeonggi-do		South Korea