Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 4. Subjects who are heavy smoker (more than 21 cigarettes per day) and alcohol addicts (more than 80 g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 5. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 6. Pregnant or lactating women or women expect to be pregnant during this study. 7. Subjects who have cognitive disorder or who have possibility of the disorder. 8. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 9. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the serum CPK level from pre-exercise | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum CPK level 2. Visual analogue scale 3. Total exercise duration and change of exercise duration from pre-exercise 4. Fatigue related biochemical examination of blood 5. Adverse event | — |
Countries
Japan
Contacts
University of Miyazaki Clinical research support center, university of Miyazaki hospital