Blood Sugar
Conditions
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
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
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose level | Baseline, week 12 | blood glucose level detection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactJonghee Sohn, MS
Backup ContactHyunJin Nam
Outcome results
None listed