The healthy adults who routinely take exercise.
Conditions
Interventions
The subjects are instructed to take 150 ml of fermented milk beverage made with koji mold named "
HYAKUBYAKUKOJI"
at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
The subjects are instructed to take 150 ml of "
Pocari Sweat"
with 28g of glucose at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who routinely take exercise (Average more than one-hour exercise per day). 3. Subjects who have no abnormality in clinical problems by screening tests. 4. 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. 2. Subjects who can't take exercise tolerance by bicycle ergometer. 3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to dairy product including milk and rice. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who don't take dairy product and rice even if there is any reason. 8. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. Pregnant or lactating women or women expect to be pregnant during this study. 11. Subjects who have cognitive disorder or who have possibility of the disorder. 12. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 13. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum rotational speed on 10 seconds high power test by bicycle ergometer at pre- and post- exercise tolerance, four-hour rest after exercise, and the next day. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue related scales (VAS, modified Borg scale) 2. Fatigue related biochemical examination of blood and urine 3. Amino acid analysis 4. Adverse events. (They are assessed at pre- and post-exercise tolerance, four-hour rest after exercise, and the next day except for adverse events.) | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed