UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039161 |
|---|---|
| Receipt number | R000044572 |
| Scientific Title | Benefit of brown rice and white rice on cognitive functions in the elderly |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2022/04/22 11:38:02 |
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Basic information
Public title
Benefit of brown rice and white rice on cognitive functions in the elderly
Acronym
Benefit of brown rice and white rice on cognitive functions in the elderly
Scientific Title
Benefit of brown rice and white rice on cognitive functions in the elderly
Scientific Title:Acronym
Benefit of brown rice and white rice on cognitive functions in the elderly
Region
| Japan |
Condition
Condition
Healthy older adults with a normal cognitive function and mild cognitive impairment.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect of brown rice on cognitive functions in elderly adults with a normal cognitive functions and mild cognitive impairments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (FAB)
Key secondary outcomes
Cognitive test (MMSE, stroop, CANDy: Conversational Assessment of Neurocognitive Dysfunction, S-A creativity test, epistemic curiosity scale)
psychological test (TIPI-J, GHQ12, WHO-5, Visual analogue scale)
autonomic test (photoplethysmogram, FitBit Flex2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Eating brown rice once a day, 4 times a week for 24 weeks
Interventions/Control_2
Eating white rice 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females aged over 60 in facilities for the elderly (elderly housing with services, day services, nursing homes, etc.).
Those whose cognitive function ranges from normal to mild cognitive impairment, and who has written consent to participate in this study.
Those who can eat brown rice or white rice one meal a day, four days a week during the study period and continue it for 6 months.
Key exclusion criteria
We will exclude the subjects with dementia, Alzheimer, MMSE score of less than 23, visual impairment, hearing impairment.
Those who have taken brown rice continuously in the last year.
In addition, person who have difficulty performing cognitive tests.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Smart-Aging Research Center, Tohoku University
Division name
Joint Research Division for Nutrition & Cognitive Health (Toyo Rice Corp.)
Zip code
980-8575
Address
4-1, Seiryo-machu, Aoba-ku, Sendai-shi, Miyagi, 980-8575, Japan
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Takano |
Organization
Smart-Aging Research Center, Tohoku University
Division name
Joint Research Division for Nutrition & Cognitive Health (Toyo Rice Corp.)
Zip code
980-8575
Address
4-1, Seiryo-machu, Aoba-ku, Sendai-shi, Miyagi, 980-8575, Japan
TEL
022-717-8561
Homepage URL
yuji.takano.a6@tohoku.ac.jp
Sponsor or person
Institute
Smart-Aging Research Center, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Toyo Rice Corp.
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
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044572
| Research Plan | |
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| Registered date | File name |
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