Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GTE, Placebo.
- Who it may be relevant to
- Registry conditions: Blood Sugar. Basic parameters: 19 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 supplement GTE
oral administration of GTE tablets once daily for 12 weeks - Dietary supplement Placebo
oral administration of placebo tablets once daily for 12 weeks
Primary outcome measures
- Change in fasting glucose level [Time frame: Baseline, week 12]
Secondary outcome measures (4)
- changes of indicator of lipid metabolism [Time frame: Baseline, week 12]
- OGTT [Time frame: Baseline, week 12]
- blood biomarkers [Time frame: Baseline, week 12]
- change in waist circumference(cm) [Time frame: Baseline, week 12]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
South Korea · 3 centers
- Kangbuk samsung hospital — Seoul
- Seoul National Universtiy Hospital — Seoul
- The Catholic University of Korea St. Vincent's Hospital — Seoul
Identifiers
NCT: NCT06592365 · AP-R-2019-01