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

Not Applicable

Recruiting

• Conditions: Blood Sugar
• Interventions: Dietary Supplement: GTE; Dietary Supplement: Placebo

• Registration Number: NCT06592365
• Lead Sponsor: Amorepacific Corporation

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

Study Timeline

• Study Start: 2022-08-08
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GTE (Green tea extract)	GTE	three tablets once daily
Placebo	Placebo	three tablets once daily

Primary Outcome Measures

Name	Time	Method
Change in fasting glucose level	Baseline, week 12	blood glucose level detection

Secondary Outcome Measures

Name	Time	Method
changes of indicator of lipid metabolism	Baseline, week 12	Total cholesterol, HDL, LDL, TG
OGTT	Baseline, week 12	oral glucose tolerance test
blood biomarkers	Baseline, week 12	insulin etc.
change in waist circumference(cm)	Baseline, week 12	-waist circumference was measured using WHO guideline

Trial Locations

Locations (3)

Kangbuk samsung hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National Universtiy Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea St. Vincent's Hospital; 🇰🇷 Seoul, Korea, Republic of