Clinical Study to Evaluate the Effects and Safety of Gree... | NCT06592365

Studies
Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation

NCT06592365

Sponsor

Amorepacific Corporation

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Blood Sugar

Interventions

GTE
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

Aug 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

Aug 8, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Aug 20, 2024

First Submission Date that Met QC Criteria

Sep 9, 2024

First Posted Date

Sep 19, 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 9, 2024

Last Update Posted Date

Sep 19, 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

FDAAA801 Violation

Not provided

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

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GTE (Green tea extract)	Active Comparator	three tablets once daily	Dietary Supplement: GTE
Placebo	Placebo Comparator	three tablets once daily	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GTE	Dietary Supplement	oral administration of GTE tablets once daily for 12 weeks	GTE (Green tea extract)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fasting glucose level	blood glucose level detection	Baseline, week 12

Secondary Outcomes

Measure	Description	Time Frame
changes of indicator of lipid metabolism	Total cholesterol, HDL, LDL, TG	Baseline, week 12
OGTT	oral glucose tolerance test	Baseline, week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females aged between 19 to 64 years
BMI between 18.5 and 29.9kg/m²
fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
subjects who voluntarily decide to participate in this study and sign the informed consent form.

Exclusion Criteria:

Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
Individuals diagnosed with diabetes and who have taken medications related to blood glucose
Individuals congenital enzyme deficiencies related to sugar metabolism.
with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
Individuals ongoing treatment diseases significantly related glucose metabolism.
Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
Individuals with renal disorder
Individuals with a weight change of 5 kg or more within the last 3 months.

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, MS	Contact	800-555-5555		sohnjh@amorepacific.com
HyunJin Nam	Contact	800-555-5555		hjnam@amorepacific.com

Overall Officials

Name	Affiliation	Role
Jae-Heon Kang, MD, PhD	Kangbuk Samsung Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk samsung hospital	Recruiting	Seoul			South Korea