Healthy Japanese
Conditions
Interventions
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Duration>
Period I: Tea beverage Period II: Placebo beverage *The intervention sequence is Period I to Period II. *Washout period is for one week and more.
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Period I: Placebo beverage Period II: Tea beverage *The intervention sequence is Period I to Period II. *Washout period is for one week and more.
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose fasting blood glucose level is 110-125 mg/dL or whose maximum blood concentration (Cmax) of the glucose after consumption of carbohydrate load is 140-199 mg/dL at screening (before consumption; Scr) 6. Individuals whose fasting blood insulin level is 2.2-12.4 micro U/mL at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who use or take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who take medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines, the test food related products, tea, wheat, milk ingredients, eggs, and/or soybeans 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician 10. Individuals whose physical condition is impaired easily by caffeine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The maximum blood concentration (Cmax) of the glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of the blood glucose levels from before to 30, 60, 90, and 120 minutes after consumption of test food 2. The total AUC (TAUC) of the blood glucose levels from before to 30, 60, 90, and 120 minutes after consumption of test food 3. The measured value of blood glucose level at 30, 60, 90, and 120 minutes after consumption of the test food 4. The amount of change of blood glucose level from before to 30, 60, 90, and 120 minutes after consumption of the test food 5. The feeling of satiety measured by visual analog scale (VAS) before and immediately, 30, 60, 90, and 120 minutes after consumption of the test food 6. The IAUC of the feeling of satiety measured by VAS from before to 120 minutes after consumption of test food | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed