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

Amorepacific

Status: Enrolling

Conditions: Blood Sugar

Treatments: Dietary Supplement: GTE; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06592365

AP-R-2019-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 84 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

GTE (Green tea extract)

Active Comparator group

Description:

three tablets once daily

Treatment:

Dietary Supplement: GTE

Placebo

Placebo Comparator group

Description:

three tablets once daily

Treatment:

Dietary Supplement: Placebo