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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011526
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Graduate School of Frontier Sciences, The University of Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013294


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