Evaluating green tea extract for blood sugar control
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
This study is testing if green tea extract can help people control their blood sugar levels better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | Amorepacific Corporation Industry-sponsored |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT06592365 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effects of green tea extract on blood glucose regulation over a 12-week period. It employs a randomized, double-blind, placebo-controlled, parallel design to ensure the reliability of results. Participants will receive either the green tea extract or a placebo to assess its impact on their blood sugar levels. The study aims to provide insights into the potential benefits of green tea in managing blood glucose.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 19 to 64 years with a BMI between 18.5 and 29.9 kg/m² and fasting blood glucose levels between 100 and 139 mg/dL.
Not a fit: Patients diagnosed with diabetes or those taking medications related to blood glucose management will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a natural approach to help regulate blood sugar levels in individuals at risk of developing diabetes.
How similar studies have performed: While there have been studies on the effects of green tea on health, this specific approach to blood glucose regulation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul and 2 other locations
- Kangbuk samsung hospital — Seoul, South Korea (Recruiting)
- Seoul National Universtiy Hospital — Seoul, South Korea (Completed)
- The Catholic University of Korea St. Vincent's Hospital — Seoul, South Korea (Completed)
Study contacts
- Principal investigator: Jae-Heon Kang, MD, PhD — Kangbuk Samsung Hospital
- Study coordinator: Jonghee Sohn, MS
- Email: sohnjh@amorepacific.com
- Phone: 800-555-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.