Japanese adult people with HbA1c levels between 7.0 and 8.0% ranges
Conditions
Interventions
Duration: 8 weeks Active food: DiBloTrig(R) Administration: Take one pack of test material by dissolving it in a glass of water or warm water before each meal (before breakfast, lunch, and dinner, 3
Sponsors
ORTHOMEDICO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult people 2. Subjects with HbA1c levels between 7.0 and 8.0% ranges 3. Subjects who are judged as eligible to participate in the study by the principal investigator
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment 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 use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 7. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c: NGSP) * Compare the HbA1c levels between at the registration and 8 weeks after consuming. | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c, Blood glucose level, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglyceride (TG) * For HbA1c, compare the levels between at the registration and 4 weeks after consuming. For the other outcomes, compare the levels among at the registration and 4 and 8 weeks after consuming. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed