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
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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RECRUITING
NA
84 participants
INTERVENTIONAL
2022-08-08
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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GTE (Green tea extract)
three tablets once daily
GTE
oral administration of GTE tablets once daily for 12 weeks
Placebo
three tablets once daily
Placebo
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
Placebo
oral administration of placebo tablets once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
64 Years
ALL
Yes
Sponsors
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Amorepacific Corporation
INDUSTRY
Responsible Party
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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
Seoul National Universtiy Hospital
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AP-R-2019-01
Identifier Type: -
Identifier Source: org_study_id
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