Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing proanthocianidins derived from Acacia Bark Glucose load (the examination before test-food consumption): "
(200 g
retort cooked rice) Administration: 1. During test-food consumption: Take six tablets with water without chewing before meals. * If you forget to take the test food, take it as soon as you remembe
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who have relatively high levels of blood glucose, or being anxious about or suffering their blood glucose 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who are between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before test-food consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 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 or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of fasting blood glucose level at 12 weeks after the start of test-food consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ratio of the number of subjects who are less than 110 mg/dL in fasting blood glucose level at 12w 2. The measured value of fasting blood glucose level at eight weeks after the start of test-food consumption (8w) 3. The measured value of fasting blood glucose level at four weeks after the start of test-food consumption (4w) 4. The change values of fasting blood glucose levels between at the examination before start of test-food consumption and at 4w, 8w and 12w 5. IAUC0-30, IAUC0-60, IAUC0-90, IAUC0-120 and Cmax at the examination before test-food consumption (with glucose load) 6. The measured values of blood glucose levels at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load) 7. The change values of blood glucose levels before glucose load and at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load) 8-1. The measured values of hemoglobin A1c (HbA1c: NGSP) level at 12w 8-2. The change values of hemoglobin A1c (HbA1c: NGSP) level between at the examination before start of test-food consumption and at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed