Healthy Japanese subjects
Conditions
Interventions
Whey protein with malted rice <
Whey protein without malted rice Administration: Dissolve one packet of the test food in water (100 mL) and drink within five minutes. *The intervention sequence is Period I to Period II, and ea
Whey protein without malted rice <
Whey protein with malted rice Administration: Dissolve one packet of the test food in water (100 mL) and drink within five minutes. *The intervention sequence is Period I to Period II, and each
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Female 3. Subjects aged 50 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 take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 8. Subjects whose dinner time is irregular 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who suffer from COVID-19 11. 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 12. Subjects who are judged as ineligible to participate in the 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 maximum blood concentration (Cmax), the time to maximum blood concentration (Tmax), and the measured values and the amount of change from before test-food consumption at each assessment point*1 of total amino acid 2. The IAUC, Cmax, Tmax, and the measured values and the amount of change from before test-food consumption at each assessment point*1 of each following item: plasma amino acids fractionation, Fischer ratio, branched-chain amino acids (BCAA), essential amino acids, and nonessential amino acids *1It indicates before test-food consumption, at 15, 30, 45, 60, 75, 90, and 120 minutes after test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed