Effects of consumption of the test food on the blood glucose level in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000047846
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
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. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 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 suffer from COVID-19 9. 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 10. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incremental area under the curve (IAUC) of the postprandial blood glucose level
- Secondary Outcome Measures
Name Time Method 1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. Blood glucose level before and 30, 60, 90, and 120 minutes after glucose load 3. The amount of change of blood glucose level between before and 30, 60, 90, and 120 minutes after glucose load 4. Insulin and 1,5-anhydroglucitol (1,5-AG), hemoglobin A1c (HbA1c), total homocysteine, pentadecanoic acid, HOMA-beta, and HOMA-IR* *HOMA-beta = (fasting blood insulin level (micro-U/mL) x 360) / (fasting blood glucose level (mg/dL) - 63) HOMA-IR = fasting blood insulin level (micro-U/mL) x fasting blood glucose level (mg/dL) / 405