Healthy Japanese
Conditions
Interventions
<
Duration>
Test food: Comeat(R) (fermented rice product, 128.9 g) <
Sato No Gohan (150 g) <
Test food: Add 100 mL of hot water to the test food, wait 5 minutes, and consume within 10 minutes. If consuming within 10 minutes is difficult, consume within 15 minutes. Carbohydrate load: Consume
Sponsors
Agro Ludens Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 20 or more and less than 50 4. Healthy individuals 5. Individuals whose body mass index (BMI) is less than 30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who have food allergies and/or food intolerances. Particularly, individuals who have lactose intolerance. 6. Individuals who have abnormal glucose tolerance 7. Individuals who take medications known to affect glucose tolerance 8. Individuals who have used insulin for diabetes or taken antihyperglycemic drugs 9. Individuals who have been hospitalized for treatment or surgery within the last three months 10. Individuals who plan to have surgery within two weeks after this study 11. Individuals who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients 12. Individuals who are taking steroids, protease inhibitors, or antipsychotics 13. Individuals who are taking or using medicines (including herbal medicines) or supplements 14. Individuals who are allergic to medicines or foods related to the test product 15. Individuals who are pregnant, lactating, or planning to become pregnant during this study 16. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 17. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The GI of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood glucose levels at 15, 30, 45, 60, 90, and 120 minutes after intervention, and the maximum blood concentration (Cmax) 2. Incremental area under the curve (IAUC) of total cholesterol and triglyceride 3. Total cholesterol and triglyceride levels at 30, 60, and 120 minutes after intervention and their Cmax | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed