UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020600 |
|---|---|
| Receipt number | R000023455 |
| Scientific Title | Study of functional peptide on maintenance of healthy mind and body |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2020/07/21 10:45:25 |
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Basic information
Public title
Study of functional peptide on maintenance of healthy mind and body
Acronym
Study of functional peptide
Scientific Title
Study of functional peptide on maintenance of healthy mind and body
Scientific Title:Acronym
Study of functional peptide
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment (MCI)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Interventions for the individuals with Mild Cognitive Impairment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wechsler Memory Scale-R Logical Memory,
12 weeks after the intervention
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Functionalpeptide 1g per day for 12 weeks
Interventions/Control_2
Placebo control
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
| 50 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Mild Cognitive Impairment
Key exclusion criteria
not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Asada |
Organization
Memory Clinic Ochanomizu
Division name
Medical care Division
Zip code
1130034
Address
1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL
03-6801-8718
tasada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
The University of Tokyo
Division name
GSFS
Zip code
2778562
Address
Kashiwanoha, Kashiwa, Chiba
TEL
04-7136-3632
Homepage URL
hisatsune@k.u-tokyo.ac.jp
Sponsor or person
Institute
Hisatsune Lab, GSFS, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants from KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Brain Function Laboratory, Inc.
Name of secondary funder(s)
Grants from Industories
IRB Contact (For public release)
Organization
GSFS, The University of Tokyo
Address
5-1-5 Kashiwanoha, Kashiwa
Tel
08036955797
k-kenkyu@adm.k.u-tokyo.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
| 2016 | Year | 01 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2016 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023455
| 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 |
