UMIN-CTR Clinical Trial

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
Email	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
Email	yuji.takano.a6@tohoku.ac.jp

Sponsor
Institute	Smart-Aging Research Center, Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044572