Healthy male
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male university students belonging to a track and field club (or equivalent) who specialize in long-distance running of 5000m or longer. 2. Individuals aged 18 to less than 26 years at the time of obtaining informed consent. 3. Individuals whose personal best record in an official 5000m race within the past year is between 14 minutes 00 seconds and 15 minutes 30 seconds. 4. Individuals who agree not to change their dietary habits during the study period. 5. Healthy individuals with no chronic physical diseases. 6. Individuals who have received a full explanation regarding the purpose and content of the study, possess the capacity to consent, fully understand the study, voluntarily desire to participate, and are able to provide written consent. 7. Individuals able to undergo measurements on the designated dates.
Exclusion criteria
Exclusion criteria: 1. Individuals with symptoms of any chronic disease. 2. Individuals with a history or current history of severe hepatic, renal, cardiac, pulmonary, or hematological disorders. 3. Individuals with comorbidities or a history of gastrointestinal diseases (however, a history judged by the principal investigator not to affect study participation is acceptable). 4. Individuals with food allergies (including a history of such allergies). 5. Individuals with alcohol dependence or other psychiatric disorders. 6. Individuals with severe anemia. 7. Individuals with a smoking habit. 8. Individuals likely to change their lifestyle habits during the study period (e.g., night shifts, long-term travel). 9. Individuals planning to start taking new Foods with Health Claims or supplements during the study period. 10. Individuals who have had a period of training interruption due to injury lasting 1 week or more within the past 2 months. 11. Individuals who have received treatment requiring hospitalization within the past 6 months. 12. Individuals currently participating in other human studies, or within 3 months after participating in other human studies. 13. Others judged by the principal investigator to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal parameters (GI symptoms, Blood I-FABP, IL-6, Cortisol) Ease of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Perceived exertion Adverse events (presence and severity) | — |
Countries
Japan
Contacts
Morinaga & Co., Ltd. Health Science and Research Center, R&D institute