Healthy Japanese subjects
Conditions
Interventions
Period I: Black tea Period II: Placebo drink * The intervention sequence is Period I to Period II, and each beverage is single ingestion. * Take the test drink (200 mL) with the rice (200 g) with
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who are 99 mg/dL or less in fasting blood glucose levels and relatively high
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, abnormal glucose tolerance, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of the blood glucose levels | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The levels of maximum (Cmax) blood glucose 2. Blood glucose levels at before taking the test drink, and at 30, 60, 90, 120 minutes after taking the test drink 3. IAUC of the blood insulin levels 4. The levels of maximum (Cmax) blood insulin 5. Blood insulin levels at before taking the test drink, and at 30, 60, 90, 120 minutes after taking the test drink | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed