Healthy Japanese
Conditions
Interventions
<
Duration>
Test 1: High protein powder Test 2: Commercially available milk (Meiji Oishii Gyunyu) <
Test 1: Dissolve 20 g of high protein powder in 442 mL of water and consume it within 15 minutes after completing the pre-consumption measurement. Test 2: Consume 442 mL within 15 minutes after compl
Test 1: Commercially available milk (Meiji Oishii Gyunyu) Test 2: High protein powder <
Test 1: Consume 442 mL within 15 minutes after completing the pre-consumption measurement. Test 2: Dissolve 20 g of high protein powder in 442 mL of water and consume it within 15 minutes after compl
Sponsors
PlasMEDi Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged between 20 and 60 4. Healthy individuals 5. Individuals whose body mass index (BMI) is less than 30 kg/m2 at screening
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 medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals whose lifestyles are irregular due to working a late-night shift or others 8. Individuals who have food allergies or food intolerances, particularly lactose intolerance 9. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods 10. Individuals who have or are undergoing medical treatment for diseases that influence digestion and absorption of nutrients 11. Individuals who are taking steroids, protease inhibitors, or antipsychotics 12. Individuals who are smokers 13. Individuals who have difficulty consuming the food in the prescribed administration 14. Individuals who are pregnant, lactating, or planning to become pregnant during this study 15. 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 16. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of total amino acid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The time to maximum blood concentration (Tmax) and maximum blood concentration (Cmax) of total amino acids, measured values, and changes from pre-consumption values at each time point 2. The IAUC, Tmax, and Cmax of branched-chain amino acids (BCAA), essential amino acids (EAA), non-essential amino acids (NEAA), amino acid fractions, and Fischer ratio, as well as measured values and changes from pre-consumption values at each time point | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed