Healthy Japanese subjects
Conditions
Interventions
Duration: single dose Test Material: test food Dose: 204 g (50g of carbohydrate amount) Administration: Eat the test food with water (300 mL) within 12-15 minutes Duration: single dose Test Ma
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects ages between 20-50 years 2. Subjects who are below 30 kg/m2 in BMI 3. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 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 have food allergies and/or food intolerances 5. Subjects who take medications known to affect glucose tolerance 6. Subjects who use insulin to treat diabetes or take antihyperglycemic drugs 7. subjects who are the presence of disease or drugs which influence digestion and absorption of nutrients 8. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 9. Subjects who are currently taking medications (including herbal medicines) and dietary supplement. Particularly, the use of steroids, protease inhibitors, or antipsychotics 10. Subjects who are an allergic reaction to medications and/or the test food related products. Particularly, the presence of celiac disease or sensitive to gluten 11. Subjects who are pregnant, breast-feeding, or planning to become pregnant 12. Subjects who have a major medical or surgical event requiring hospitalization within the preceding 3 months 13. 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 trials during trial period 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GI * Based on ISO 26642 | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed