Healthy Japanese subjects
Conditions
Interventions
Single ingestion of test food
Single ingestion of placebo
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. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose Cmax of postprandial blood glucose are between 140 mg/dL and 199 mg/dL at screening (before consumption; Scr) 7. Subjects whose IAUC of postprandial blood glucose are relatively large at Scr
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 under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who 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 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of the postprandial blood glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. IAUC and Cmax of the blood insulin levels 3. The blood glucose level before consumption the test food and at 30, 60, 90, and 120 minutes after consumption the test food 4. The blood insulin level before consumption the test food and at 30, 60, 90, and 120 minutes after consumption the test food 5. HOMA-IR, HOMA-beta, and insulin index* *HOMA-IR = fasting blood insulin level (micro-U/mL) x fasting blood glucose level (mg/dL) / 405 HOMA-beta = (fasting blood insulin level (micro-U/mL) x 360) / (fasting blood glucose level (mg/dL) - 63) Insulin index = increase of blood insulin level (30 min - 0 min: micro-U/mL) / increase of blood glucose level (30 min - 0 min: mg/dL) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed