Blood Glucose, High
Conditions
Brief summary
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (\< 30 kg/m2) and fasting glucose level of \> 100 mg/dL after high-fat/high-carbohydrate meal.
Interventions
DIETARY_SUPPLEMENTAP green tea extract
single intake of AP green tea extract
Sponsors
Amorepacific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects aged 19 years or over * BMI \< 30 kg/m2 * Fasting glucose level \> 100 mg/dL (who is not under medication) * Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives
Exclusion criteria
* At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication * Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product * Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis * In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Blood glucose level | 0 - 300 minute | Change of Blood glucose level before and after high-carbohydrate/high-fat meal |
| Change of Insulin level | 0 - 300 minute | Change of Insulin level before and after high-carbohydrate/high-fat meal |
| Change of Triglyceride level | 0 - 300 minute | Change of Triglyceride level before and after high-carbohydrate/high-fat meal |
Countries
South Korea
Outcome results
None listed