Effects of Daily Ingestion of the Food Containing Rice Bran Fermented Product Combined with Light Exercise on Cognitive Function and Muscle Mass: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000050287
• Lead Sponsor: Hokkaido Information University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-10
• Last Update Posted: 17 October 2023
• Study Completion: 2023-12-04

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects whose MMSE score is <= 23 points. 2. Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease. 3. Subjects who have a history or are suspected patient of cranial nerve disease and psychiatric disorders. 4. Subjects with musculoskeletal disorders or injuries that limit physical activity. 5. Subjects who receiving exercise therapy, or who have been restricted from exercising by a physician. 6. Subjects with implantable electronic medical devices. 7. Subjects who are under treatment or have a history of serious diseases, or who affected with infectious diseases requiring reports to the authorities. 8. Subjects with major surgical history relevant to the digestive system. 9. Subjects with significant abnormalities on clinical and physical examination. 10. Subjects with severe anemia. 11. Subjects with dysphagia. 12. Subjects who have performed a cognitive test similar to this study within 3 mos. prior to this study. 13. Subjects who are difficult to perform cognitive tests. 14. Subjects who are unable to perform the specified exercise program. 15. Subjects who may develop allergies related to the study 16. Subjects who regularly take medicine, functional foods which would affect cognitive function or muscle mass. 17. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18. Subjects who habitually engage in strenuous physical activities. 19. Subjects who are engaged in physical labor. 20. Subjects who donated either 400 ml whole blood within 16 wks. (women), 12 wks. (men), 200 ml whole blood within 4 wks., or blood components within 2 wks., prior to this study. 21. Subjects who feel bad mood by blood collection. 22. Subjects who currently participate in other clinical trials, or participated within the last 4 wks. prior to this study. 23. Subjects whose lifestyle is expected to change during the study period. 24. Subjects who are ineligible due to physician's judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified