Status:
RECRUITING
Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
Lead Sponsor:
Amorepacific Corporation
Conditions:
Blood Sugar
Eligibility:
All Genders
19-64 years
Phase:
NA
Brief Summary
This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level
Detailed Description
This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06592365
Start Date
August 8 2022
End Date
December 31 2024
Last Update
September 19 2024
Active Locations (3)
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1
Kangbuk samsung hospital
Seoul, South Korea
2
Seoul National Universtiy Hospital
Seoul, South Korea
3
The Catholic University of Korea St. Vincent's Hospital
Seoul, South Korea