Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
Led by Amorepacific Corporation · Updated on 2024-09-19
84
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of green tea extract on blood sugar regulation. This 12-week study uses a randomized, double-blind, placebo-controlled design to compare green tea extract tablets with placebo tablets in adults aged 19 to 64 years who have elevated fasting blood glucose levels. The study aims to see if green tea extract can reduce blood glucose levels and affect related metabolic indicators. Participants will be randomly assigned to take either three green tea extract tablets or three placebo tablets once daily for 12 weeks. The study groups receive their assigned tablets orally each day during this period. The design ensures that neither participants nor researchers know who receives the active supplement or placebo until the study concludes. During the study, participants will have their fasting glucose levels measured at the start and after 12 weeks. Researchers will also assess lipid metabolism markers, oral glucose tolerance tests, blood biomarkers, and waist circumference at these times. This includes safety monitoring and evaluation of any changes in these health measures over the study period. The total participation time is 12 weeks.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged between 19 to 64 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m²
- Fasting blood glucose between 100 and 139 mg/dL (excluding those requiring medication for levels 126-139 mg/dL)
- Voluntary participation with signed informed consent
You will not qualify if you...
- Taking medication for obesity, dyslipidemia, or uncontrolled hypertension at screening
- Diagnosed with diabetes and on blood glucose medications
- Congenital enzyme deficiencies affecting sugar metabolism
- Allergic or sensitive to green tea or caffeine
- Undergoing treatment for diseases significantly related to glucose metabolism
- History of surgery related to glucose metabolism within the last 6 months
- Diagnosed with gastrointestinal, cardiovascular, thyroid disorders, uncontrolled chronic conditions, or active malignant tumors requiring medication
- Liver impairment, acute or chronic hepatitis, or liver cirrhosis
- Renal disorders
- Weight change of 5 kg or more within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take oral tablets once daily for 12 weeks to evaluate the effects and safety of green tea extract on blood glucose regulation.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 3 locations
1
Kangbuk samsung hospital
Seoul, South Korea
Actively Recruiting
2
Seoul National Universtiy Hospital
Seoul, South Korea
Completed
3
The Catholic University of Korea St. Vincent's Hospital
Seoul, South Korea
Completed
Research Team
J
Jonghee Sohn, MS
H
HyunJin Nam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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