Healthy male adults
Conditions
Interventions
The test food is ingested once.
The control food is ingested once.
Sponsors
Transgenic Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Men aged 20 years or older at the time of consent and under 65 years old at the end of the study (2) Subjects who can be admitted to a designated facility on the scheduled date of visit (3) Subjects who can enter data into an electronic diary using a PC, smartphone, etc. (4) Those who have fully understood the purpose and content of this study and have obtained written consent.
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure less than 90 mmHg. 2. Donated blood components or 200 mL or more whole blood within 4 weeks before study start. 3. Donated 400 mL or more whole blood within 12 weeks before study start. 4. Total blood drawn from the month before study start plus planned study draws exceeds 1200 mL. 5. Participating in other studies within 4 weeks after another study or planning other study participation during this study. 6. Any of the following a. Heart liver gastrointestinal or kidney disease including complications b. History of circulatory disease c. Diabetes d. Allergy to test or prescribed food e. History of serious diseases such as cancer or tuberculosis 7. Undergoing medical treatment at screening SCR. 8. Regular use of drugs or quasi-drugs. 9. Smoking 11 cigarettes per day or more. 10. Average daily alcohol over 60 g or drinking more than 6 days per week. 11. Extremely irregular eating habits. 12. Shift or late-night worker. 13. Severe anemia. 14. History of poor mood or physical condition after blood sampling. 15. Difficulty with peripheral blood collection or major gastrointestinal surgery history such as gastrectomy gastrointestinal suturing or intestinal resection. 16. Deemed unsuitable by principal or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluid balance | — |
Secondary
| Measure | Time frame |
|---|---|
| Water retention rate, urinary excretion, specific gravity, pH, hematocrit, blood viscosity, ALB, NA, K, UREA Nitrogen/Creatinine, Osmolarity, Plasma Volume, Body Weight | — |
Countries
Japan
Contacts
Public ContactTakayuki Honjo
Suntory beverage & Food limited. Development & Designed Department
Outcome results
None listed