Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000037449
- Lead Sponsor
- Clinical and translatnal methodology, Fuculty of Medicine, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 36
Not provided
[At the primary registration] 1. Subjects who are treated for diabetes. 2. Subjects who are taking medications for dislipidemia hypertention, and anemia. 3. Subjects who are taking warfarin. 4. Subjects who are habitually taking medication and/or supplement (including "food for specified health use", and "foods with function claims") that affect glucose metabolism. 5.Subjects who are diagnosed for anemia or have treatment history for anemia. 6. Subjects who are difficult to collect blood in health checkup and so on oftenly. 7. Subjects who are enrollment in another interventional study. 8. Subjects who have suspected food allergy to test meal 9. Subjects who were recognized unsuitable for this study by the Investigator. [At the secondary registration] 1. Subjects who are confirmed to be difficult to collect blood during continuous blood collection using indwelling needle 2. Subjects who were recognized unsuitable for this study by the Investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incremental area under the curve of plasma glucose (0-30 min)
- Secondary Outcome Measures
Name Time Method 1.Incremental area under the curve of plasma glucose (0-15, 0-45, 0-60, 0-90, 0-120 min) 2.The level and change from baselaine of plasma glucose (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 3.The level and change from baseline of plasma insulin (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 4.Organoleptic evaluation (eating quality of test meal)