Healthy adult
Conditions
Interventions
Consecutive intake of test food and protein once a day for 15 days
Consecutive intake of placebo food and protein once a day for 15 days
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females from 18 to 29 years of age 2. Subjects whose BMI is less than 20 kg/m2 3. Subjects who defecate more than 3 times a week without laxative 4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who have a positive or false positive result in any infectious disease test or who are carriers 2. Subjects who have any food allergies 3. Subjects who may develop allergies in relation to the study 4. Subjects who are taking healthy foods 5. Subjects who are prescribed medicines containing enzymes that enhance protein digestion and absorption, or gastric acid secretion regulators 6. Subjects who are prescribed laxatives or medicines or quasi-drugs that affect the intestinal flora 7. Subjects who regularly consume probiotic or prebiotic foods and beverages as part of their daily diet 8. Subjects who regularly consume foods or supplements that claim to contain enzymes supporting protein digestion, including digestive enzyme supplements 9. Subjects who are currently undergoing treatment or who have a disease that requires treatment 10. Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function 11. Subjects who have a disease requiring regular medication, including seasonal medication, during the study period, or those with a history of serious illness that required medication 12. Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range 13. Subjects who have an irregular lifestyle, such as shift work or late-night work, and are unable to sleep the night before the test 14. Subjects who are participating in the other study within one month before the start of this study 15. Subjects who plan to travel or go on business trips abroad, long-term domestic travel or business trips, or frequent domestic business trips or domestic travel 16. Subjects who plan to become pregnant or breastfeed during the study period 17. Subjects who are judged to be unsuitable as subjects based on the answers to the background survey 18. Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood amino acids ( total amino acids, essential amino acids, branched-chain amino acids) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood amino acid profile, Total Protein, Albumin, Total cholesterol, Hemoglobin | — |
Countries
Japan
Contacts
Public ContactKaori Yoshimura
EP Mediate Co., Ltd. Development Department
Outcome results
None listed