UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032624 |
|---|---|
| Receipt number | 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 09:45:46 |
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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
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
rui.nouchi.a4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
