RecruitingNot ApplicableNCT06592365

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation


Sponsor

Amorepacific Corporation

Enrollment

84 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 YearsMax Age: 64 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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.

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Interventions

DIETARY_SUPPLEMENTGTE

oral administration of GTE tablets once daily for 12 weeks

DIETARY_SUPPLEMENTPlacebo

oral administration of placebo tablets once daily for 12 weeks


Locations(3)

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

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NCT06592365


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