Healthy Japanese
Conditions
Interventions
Duration: Single ingestion (three times) Test product: <
Protein derived from test material A <
Soy protein <
Milk protein (whey protein) Intake method: Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the
Milk protein (whey protein) <
Protein derived from test material A Intake method: Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water aga
Soy protein Intake method: Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker co
Sponsors
Mitsubishi Corporation Life Sciences Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged >= 20 and < 60 4. Healthy individuals 5. Individuals whose BMI is >= 18.5 kg/m2 and < 25.0 kg/m2 at screening 6. Individuals whose systolic blood pressure is < 140 mmHg and diastolic blood pressure is < 90 mmHg at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator 3. Individuals who are 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, particularly those allergic to glutathione, soy, or milk 7. Individuals who drink pure alcohol an average of >= 60 g/day a week 8. Individuals who are smokers or have quit smoking within the last year 9. Individuals whose lifestyles or dietary habits are irregular due to working a late-night shift or others 10. Individuals who have food allergies or food intolerances including the test foods and the prescribed food 11. Individuals who have a history of serious diseases of digestive organs, or surgical history of digestive organs 12. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods 13. Individuals who have or have a history of a diseases which influence digestion and absorption of nutrients 14. Individuals who are taking steroids, protease inhibitors, or antipsychotics 15. Individuals who are pregnant, lactating, or planning to become pregnant during this study 16. 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 17. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The time to maximum blood concentration (Tmax) of total amino acid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC), and the maximum blood concentration (Cmax) of total amino acid, the measured values at each measurement point, and the changes from measurements before consuming the test products 2. IAUC, Tmax, Cmax, the measured values at each measurement point, and the changes from measurements before consuming the test products to each measurement point of branched-chain amino acids (BCAA), essential amino acid (EAA), non-essential amino acid (NEAA), plasma amino acids fraction, and Fischer ratio 3. The measured values of "hunger" and "satiety" at each measurement point | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed