Healthy Japanese
Conditions
Interventions
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Duration>
Test 1: Food 1 Test 2: Food 2 *Test 1 followed by Test 2. *The washout period is at least one week.
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Test 1: Food 2 Test 2: Food 1 *Test 1 followed by Test 2. *The washout period is at least one week.
Sponsors
Raffinee International Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medicines (including herbal medicines) or supplements 6. Individuals with allergies (related to pharmaceuticals, test products, or food), particularly with allergies to wheat, soybeans, or chicken 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician 10. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day 11. Individuals who take dairy products such as milk and cheese at least four times a week 12. Individuals who are restricting their diet or exercising for the purpose of dieting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incremental Area Under the Curve (IAUC) of lipid components | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUC, Cmax and the measured values at each measurement point of lipid components 2. Tmax, T1/2 and the changes from measurements before test product consumption of lipid components | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed