Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Female 3. Subjects 40 or over to under 80 years old 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose postprandial blood glucose level (Cmax) is 140 mg/dL to 199 mg/dL in the screening
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, 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 another 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The levels of maximum (Cmax) blood glucose 2. The blood glucose level before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department