Healthy Japanese subjects
Conditions
Interventions
Duration: Single ingestion (one term) Test food: OIKOS (plain/sweetened) Administration: Take one cup of test food (113 g) within 15 minutes after pre-consumption measurement
Duration: Single inge
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects
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. Subjects currently undergoing treatment for any of the following chronic diseases: 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," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects whose lifestyles are irregular due to working a late-night shift or others 8. Subjects who have food allergies and/or food intolerances. Particularly, subjects who have lactose intolerance. 9. Subjects who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients 10. Subjects who are taking steroids, protease inhibitors, or antipsychotics 11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12. Subjects who suffer from COVID-19 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The area under the curve (AUC) of plasma amino acids fraction, Fischer ratio, total amino acid, branched-chain amino acids (BCAA), essential amino acid (EAA), and non-essential amino acid (NEAA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The time to maximum blood concentration (Tmax) of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA 2. The maximum blood concentration (Cmax) of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA 3. The measured values of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA at each measurement point 4. The changes of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA from pre-consumption to each measurement point | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed