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

NCT ID: NCT06592365

Last Updated: 2024-09-19

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2024-12-31

Brief Summary

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This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level

Detailed Description

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This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design

Conditions

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Blood Sugar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GTE (Green tea extract)

three tablets once daily

Group Type ACTIVE_COMPARATOR

GTE

Intervention Type DIETARY_SUPPLEMENT

oral administration of GTE tablets once daily for 12 weeks

Placebo

three tablets once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

oral administration of placebo tablets once daily for 12 weeks

Interventions

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GTE

oral administration of GTE tablets once daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

oral administration of placebo tablets once daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
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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Jae-Heon Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Kangbuk samsung hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National Universtiy Hospital

Seoul, , South Korea

Site Status COMPLETED

The Catholic University of Korea St. Vincent's Hospital

Seoul, , South Korea

Site Status COMPLETED

Countries

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South Korea

Central Contacts

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Jonghee Sohn, MS

Role: CONTACT

800-555-5555

HyunJin Nam

Role: CONTACT

800-555-5555

Facility Contacts

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Jae-Heon Kang

Role: primary

Other Identifiers

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AP-R-2019-01

Identifier Type: -

Identifier Source: org_study_id

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