A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue.
- Conditions
- The healthy adults who routinely take exercise.
- Registration Number
- JPRN-UMIN000024254
- Lead Sponsor
- niversity of Miyazaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.)