UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036461 |
|---|---|
| Receipt number | R000041553 |
| Scientific Title | Acute benefits of Wasabi tablets on cognition and neural activity |
| Date of disclosure of the study information | 2019/04/10 |
| Last modified on | 2019/04/10 11:44:27 |
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Basic information
Public title
Acute benefits of Wasabi tablets on cognition and neural activity
Acronym
Acute benefits of Wasabi tablets on cognition and neural activity
Scientific Title
Acute benefits of Wasabi tablets on cognition and neural activity
Scientific Title:Acronym
Acute benefits of Wasabi tablets on cognition and neural activity
Region
| Japan |
Condition
Condition
Young Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the acute effects of Wasabi tablets on cognition and brain activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity during cognitive tasks
Key secondary outcomes
STAI:State Trait Anxiety Inventory
WHO-5:WHO Five well-being index
GHQ12:General Health Questionnaire 12
CES-D:center for epidemiologic studies depression scale
Sleep scale
brief-type self-administered diet history questionnaire
daily activities
Ten Item Personality Inventory
Effortful control scale
Profile of Mood States2
TDMS-ST:Two dimensional Mood Scale-Short Term
VAS for tastiness of Wasabi tablet
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Intake a Wasabi tablet once
Interventions/Control_2
Intake a placebo table once
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right handed Japanese native adults
Key exclusion criteria
Who
have a medical history of mental disorder or neurological disorder
take medical drug which may affect the brain and cognition
have a visual disability
Allergy for food
is participating in other intervention studies
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Tohoku University
Division name
IDAC
Zip code
9808575
Address
Seiryo 4-1, Sendai
TEL
022-717-7988
fbi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Nouchi |
Organization
Tohoku Univeristy
Division name
IDAC
Zip code
980-8575
Address
Seiryo 4-1, Sendai
TEL
022-717-8952
Homepage URL
rui@tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univerisity
Institute
Department
Personal name
Funding Source
Organization
Kinjirushi
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
IRB at Toyoku University Hospital
Address
Seiryo 1-1, Sendai city
Tel
022-728-4105
rinri-2@proj.med.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
| 2019 | Year | 04 | 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
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
| 2019 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2019 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041553
| 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 |
