UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011526 |
|---|---|
| Receipt number | R000013294 |
| Scientific Title | Brain MRI research on elderly people ingesting functional dipeptide from chicken |
| Date of disclosure of the study information | 2013/09/06 |
| Last modified on | 2018/02/22 09:25:30 |
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Basic information
Public title
Brain MRI research on elderly people ingesting functional dipeptide from chicken
Acronym
Research on elderly people ingesting functional dipeptide from chicken
Scientific Title
Brain MRI research on elderly people ingesting functional dipeptide from chicken
Scientific Title:Acronym
Research on elderly people ingesting functional dipeptide from chicken
Region
| Japan |
Condition
Condition
Prophylactic effect on brain aging
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic effect on brain aging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain MRI
Key secondary outcomes
Cognitive function
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Period: 3 months
Dose: food containing 0.5g of imidazole-dipeptide from chicken
Number of times per day: 2
Interventions/Control_2
Period: 3 months
Dose: food containing 0g of imidazole-dipeptide from chicken
Number of times per day: 2
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
| 40 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Middle-to-Elderly Volunteer
Key exclusion criteria
1. Those who have a neuropsychiatric disorder or head injury
2. When local lesions, such as a brain tumor or cerebral infarction, which affects a cognitive function by first-time MRI, are found
3. When the metal of a pacemaker, an aneurysm clip, an artificial valve, an artificial cochlea, and other magnetic bodies and electrical conductivity is contained, or a problem arises at the time of an MRI image pick-up for claustrophobia
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuhiro Hisatsune |
Organization
The University of Tokyo
Division name
Graduate School of Frontier Sciences
Zip code
Address
5-1-5 Kashiwanoha, Kashiwa, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Graduate School of Frontier Sciences
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Graduate School of Frontier Sciences, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Scientific technique research promotion program for agriculture, forestry, fisheries and food industory
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
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
| 2013 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013294
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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