UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033169 |
|---|---|
| Receipt number | R000037827 |
| Scientific Title | The effect of 'Natto' intake on brain structure and function |
| Date of disclosure of the study information | 2018/06/29 |
| Last modified on | 2018/12/28 09:43:29 |
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Basic information
Public title
The effect of 'Natto' intake on brain structure and function
Acronym
The effect of 'Natto' intake on brain structure and function
Scientific Title
The effect of 'Natto' intake on brain structure and function
Scientific Title:Acronym
The effect of 'Natto' intake on brain structure and function
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Compare the effects of 'Natto' with non-intake group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in brain structure and function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of 'Natto (60g)' for 4 weeks
Interventions/Control_2
non treatment
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
| 45 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have given written informed consent
2) Healthy subjects aged 45 to 65 years old
Key exclusion criteria
1) Person who received treatment in the past such as pacemaker, cochlear implant, cerebral artery clip
2) Claustrophobia,
3) Persons whose metals such as artificial joints are embedded in the body,
Those who put tattoos, tattoos, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Kajiwara |
Organization
Tokyo Institute of Technology
Division name
School of Life Science and Technology
Zip code
Address
4259, Nagatsuta-cho, Midori-ku, Yokohama, Kanagawa
TEL
045-924-5716
ethics@cns.pi.titech.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Koike |
Organization
Tokyo Institute of Technology
Division name
Institute of Innovative Research
Zip code
Address
4259, Nagatsuta-cho, Midori-ku, Yokohama, Kanagawa
TEL
045-924-5054
Homepage URL
ethics@cns.pi.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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 | 06 | Month | 29 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037827
