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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

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 - Effects of Daily Ingestion of the Food Containing Rice Bran Fermented Product Combined with Light Exercise on Cognitive Function and Muscle Mass

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050287
Enrollment
70
Registered
2023-02-10
Start date
2023-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Daily ingestion of test food and light exercise for 24 weeks. Daily ingestion of placebo food and light exercise for 24 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese healthy males and females aged 65-79 years old at the time of screening test. 3. Subjects who are concerned about memory loss due to aging, or whose memory loss has been pointed out by others. 4. Subjects whose relatively low the standardized score of composite memory measured by Cognitrax at the time of screening test. 5. Subjects who can write diary and questionnaire, visit an inspection facility and receive examinations in designated days.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Cognitrax, muscle mass

Secondary

MeasureTime frame
MMSE, emotion function evaluation, body composition, biochemical test

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026