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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032624
Receipt No. R000037199
Scientific Title The effects of Brain training and sulforaphane intake on cognitive functions and mental health in the elderly
Date of disclosure of the study information 2018/05/17
Last modified on 2018/05/24

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Basic information
Public title The effects of Brain training and
sulforaphane intake on cognitive functions and mental health in the elderly
Acronym The effects of Brain training and
Sulforaphane intake
Scientific Title The effects of Brain training and
sulforaphane intake on cognitive functions and mental health in the elderly
Scientific Title:Acronym The effects of Brain training and
Sulforaphane intake
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of cognitive training and nutrition intervention on car driving skills.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes processing speed (symbol search, digit symbol coding)
Key secondary outcomes Cognitive function(FAB, stroop, MMSE, Raven, JART, Logical memory, digit span, D-CAT)

Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D)


The total metabolite isothiocyanate

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 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Other
Interventions/Control_1 cognitive training(15 minutes game,everyday per week for 12 weeks) and taking sulforaphane
Interventions/Control_2 cognitive training(15 minutes game,everyday per week for 12 weeks) and taking placebo
Interventions/Control_3 puzzle training(15 minutes game,everyday per week for 12 weeks) and taking sulforaphane
Interventions/Control_4 puzzle training(15 minutes game,everyday per week for 12 weeks) and taking placebo
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
80 years-old >=
Gender Male and Female
Key inclusion criteria right handed Japanese older adults (age:60-80)
video game time is less than 1 hour per week last 2 years
Key exclusion criteria We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease, and food allergy.
In addition, person who are heavy alcoholic drinker and participated in other intervention study within 2 month and can not write a diary during the intervention period.
Target sample size 144

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kawashima
Organization IDAC, Tohoku univeristy
Division name Advanced brain science
Zip code
Address Sendai, seiryo-machi 4-1
TEL 022-717-7988
Email fbi@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rui Nouchi
Organization Tohoku University
Division name Smart aging research center
Zip code
Address Sendai, Seiryo-machi4-1
TEL 022-717-7988
Homepage URL
Email rui.nouchi.a4@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Kagome 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
Address
Tel
Email

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
2018 Year 05 Month 17 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037199

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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