Healthy Japanese subjects
Conditions
Interventions
Period I: Test food Period II: Placebo Carbohydrate load: "
retort cooked rice) * The intervention sequence is Period I to Period II, and each food is single ingestion. * Take three tablets of the test food with water at 30 minutes before taking challenge
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara 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 between >= 110 mg/dL and < 126 mg/dL in postprandial blood glucose, or >= 140 mg/dL and < 200 mg/dL in two-hour blood glucose in the 75 g OGTT
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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, 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 supplement 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 |
|---|---|
| The incremental area under the curve (IAUC) of the blood glucose levels * Measurement points are at before taking the test food, and at 30, 60, 90, 120 minutes after a glucose load. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The levels of maximum (Cmax) blood glucose 2. Blood glucose levels at each measurement point 3. IAUC of the blood insulin levels 4. The levels of maximum (Cmax) blood insulin 5. Blood insulin levels at each measurement point * Measurement points are at before taking the test food, and at 30, 60, 90, 120 minutes after a glucose load. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed