UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050287 |
|---|---|
| Receipt number | R000057262 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2024/06/26 16:36:06 |
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Basic information
Public title
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
Acronym
Effects of Daily Ingestion of the Food Containing Rice Bran Fermented Product Combined with Light Exercise on Cognitive Function and Muscle Mass
Scientific Title
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
Scientific Title:Acronym
Effects of Daily Ingestion of the Food Containing Rice Bran Fermented Product Combined with Light Exercise on Cognitive Function and Muscle Mass
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 24 weeks of daily ingestion of the food containing rice bran fermented product combined with light exercise on cognitive function and muscle mass in a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax, muscle mass
Key secondary outcomes
MMSE, emotion function evaluation, body composition, biochemical test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Daily ingestion of test food and light exercise for 24 weeks.
Interventions/Control_2
Daily ingestion of placebo food and light exercise for 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
69
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 11 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057262
