Healthy Japanese subjects
Conditions
Interventions
Period I: Active tablets Period II: Placebo tablets * The intervention sequence is I-II, and each beverage is single ingestion. * Take 2 tablets of the test food with water and then eat the presc
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who have relatively large IAUC of the blood triglyceride levels at screening (before 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 diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function Claims", or other functional food/beverage in daily. Particularly taking food/beverage effective in lowering blood sugar and anticoagulation in daily. 5. Subjects who are currently taking medications (including herbal medicines) and supplements. Particularly taking hypoglycemic agent and anticoagulants in daily. 6. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to soybeans, pork, beef, chicken, wheat, and milk. 7. Subjects who are pregnant, lactation, or 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 enroll in anther clinical trial during trial period 9. Subjects who are planning to undergo a surgical operation within two weeks from the date of finish of the intervention period 10. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood triglyceride level 2. Blood glucose level *1 Take blood samples before eating the test food and at 120, 180, 240, and 360 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 360 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood triglyceride levels of each measuring point. *2 Take blood samples before eating the test food and at 30, 60, 90, and 120 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 120 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood glucose levels of each measuring point. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin 2. HOMA-beta 3. HOMA-R 4. remnant like particles-cholesterol *1-3 Take blood samples before eating the test food. Assess the measured values at screening (before consumption) and at 1st and 2nd periods. HOMA-beta and HOMA-R are calculated by the formulas: HOMA-beta = (blood insulin level x 360) / (fasting blood glucose level - 63) HOMA-R = blood insulin level x fasting blood glucose level / 405 *4 Take blood samples before eating the test food and at 120, 180, 240, and 360 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 360 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood triglyceride levels of each measuring point. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed