Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test food: Protein processed food 1 Control food: Protein processed food 2 Administration: One pack per day at any time during the day by dissolving it well in approximately 200
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who have a protein taking habit 3. Subjects who defecate three to five times per week 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively few stool frequency during a week before screening (before test-food consumption)
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. 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 abnormal values in plasma amino acids fractionation 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Currently taking medicines (include herbal medicines) and supplements 7. Subjects who regularly use anticoagulants, such as warfarin 8. Subjects whose daily protein intake from protein drink is 25 g or more 9. Subjects who cannot stop the intake of protein drink other than the test food during this trial 10. Subjects who are planning to increase the amount of exercise during this trial 11. Subjects who are allergic to medicines and/or the test food related products, particularly milk, kiwi fruits, and latex 12. Subjects who have lactose intolerance 13. Subjects who are pregnant, breast-feeding, and planning to become pregnant 14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incremental area under the curve (IAUC) of total amino acid amount | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-1. The measured values of stool frequency, stool volume, stool days, stool shape, stool smell, exhilarating feeling at one and two weeks after the start of test-food consumption 1-2. The amount of changes of stool frequency, stool volume, stool days, stool shape, stool smell, exhilarating feeling between before test-food consumption and one and two weeks after the start of test-food consumption 2. AUC, Cmax, Tmax, and the measured values at each assessment point* of total amino acid amount 3. AUC, Cmax, Tmax, and the measured values at each assessment point* of taurine, phosphoethanolamine, aspartic acid, hydroxyproline, threonine, serine, asparagine, glutamic acid, glutamine, sarcosine, alpha-aminoadipic acid, proline, glycine, alanine, citrulline, alpha-amino-n-butyric acid, valine, cystine, methionine, cystathionine, isoleucine, leucine, tyrosine, beta-alanine, phenylalanine, beta-aminoisobutyric acid, homocysteine, gamma-aminobutyric acid, monoethanolamine, hydroxylysine, ornithine, 1-methylhistidine, histidine, lysine, 3-methylhistidine, tryptophan, anserine, carnosine, arginine, alloisoleucine, Fischer ratio (BCAA/AAA) *Each assessment point indicates before test-food consumption at 30, 45, 60, 90, 120 and 180 minutes after test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed