Healthy Japanese adult people
Conditions
Interventions
Duration: single dose Test material: Test food 1, Test food 2 Administration: Eat six of each test food without chewing in 20 minutes at the examination <
[1] Eat Test food 1 [2] Washout period is for more than a day. [3] Eat Test food 2
Duration: same as above Test material: same as above Administration: same as above <
[1] Eat Test food 2 [2] Washout period is for more than a day. [3] Eat Test food 1
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people 2. Subjects who are judged as eligible to participate in the study by the physician 3. Within the subjects who met 2nd inclusion criteria, select subjects with relatively few blood test results, which are out of the reference values at screening
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who have dysphagia 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to corn, orange, and soybean. 7. Subjects who are pregnant, breast-feeding, and 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 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level * Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food. * Assess the area under curve (AUC) between before eating the test food and 120 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood glucose level of each measuring point. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed