UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020600
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hisatsune@k.u-tokyo.ac.jp

Sponsor
Institute Hisatsune Lab, GSFS, The University of Tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.