Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician
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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have lactose intolerance 5. Subjects who have habits of strength training 6. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 7. Subjects currently taking medicines (include herbal medicines) and supplements 8. Subjects who take high-protein diets such as protein drinks or protein bars at least two times a week 9. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 10. Subjects who are pregnant, breast-feeding, and planning to become pregnant 11. Subjects who suffer from COVID-19 12. 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 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The time to maximum concentration (Tmax) of total amino acid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum blood concentration (Cmax), the incremental area under the curve (IAUC), and the measured values at each assessment point*1 of total amino acid 2. The measured values at each assessment point*1 of plasma amino acids fractionation, branched chain amino acid (BCAA), and essential amino acid for Tmax, Cmax, and IAUC 3. The measured values of the visual analogue scale (VAS) score for satiety at each assessment point*2 *1It indicates before test-food consumption, at one, two, four, and six hours after test-food consumption *2It indicates before test-food consumption, at 15, 30, 45, 60, 90, 120, and 180 minutes after test-food consumption | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department