Type 2 diabetes (Adult)
Conditions
Interventions
Duration: single dose Test material: Test food 1, Test food 2, and Test food 3 Administration: Eat six of each test food in 20 minutes at the examination * Do not drink water with test food <
[1] Eat Test food 1 [2] Washout period is for more than a day. [3] Eat Test food 2 [4] Washout period is for more than a day. [5] Eat Test food 3
Duration: same as above Test material: same
[1] Eat Test food 2 [2] Washout period is for more than a day. [3] Eat Test food 3 [4] Washout period is for more than a day. [5] Eat Test food 1
Duration: same as above Test material: same
[1] Eat Test food 3 [2] Washout period is for more than a day. [3] Eat Test food 1 [4] Washout period is for more than a day. [5] Eat Test food 2
Duration: same as above Test material: same
[1] Eat Test food 3 [2] Washout period is for more than a day. [3] Eat Test food 2 [4] Washout period is for more than a day. [5] Eat Test food 1
Duration: same as above Test material: same
[1] Eat Test food 1 [2] Washout period is for more than a day. [3] Eat Test food 3 [4] Washout period is for more than a day. [5] Eat Test food 2
Duration: same as above Test material: same
[1] Eat Test food 2 [2] Washout period is for more than a day. [3] Eat Test food 1 [4] Washout period is for more than a day. [5] Eat Test food 3
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult people 2. Patients with type 2 diabetes who are on diet therapy 3. Subjects who can obtain the family doctor's consent to the participation in this study if subjects have their family doctors 4. Subjects who can provide the latest blood test data and are allowed to participate in the study by the physician 5. Subjects who are judged as eligible to participate in the study by the physician 6. Within the subjects who met 5th inclusion criteria, subjects who are relatively few items of out-of-reference values in the blood test result at screening
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who are anemic 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. 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 (total 5 times). * Assess the area under curve (AUC), the maximum blood concentration (Cmax), and the blood glucose level between before eating the test food and 120 minutes after eating the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin 2. HOMA-beta 3. HOMA-R *1-3 Assess before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food (total 5 times). * Assess the area under curve (AUC), the maximum blood concentration (Cmax), the blood insulin, HOMA-beta and HOMA-R levels between before eating the test food and 120 minutes after eating the test food. HOMA-beta and HOMA-R are calculated by the formulas: HOMA-beta = (fasting blood insulin level x 360) / (fasting blood glucose level - 63) HOMA-R = fasting blood insulin level x fasting blood glucose level / 405 | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed