A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000038515
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.