UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032833 |
|---|---|
| Receipt number | R000037442 |
| Scientific Title | Study of the effects of casein-derived peptides on cognitive function -A randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2024/10/31 10:28:05 |
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Basic information
Public title
Study of the effects of casein-derived peptides on cognitive function -A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Effects of casein-derived peptides on cognitive function
Scientific Title
Study of the effects of casein-derived peptides on cognitive function -A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Effects of casein-derived peptides on cognitive function
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of the casein-derived peptides on cognitive function in healthy adult
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychological tests (ADAS-Jcog)
Key secondary outcomes
Neuropsychological tests (HDS-R, MoCA-J)
QOL
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food for 24 weeks
Interventions/Control_2
Ingestion of placebo for 24 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are age of 40 years or older.
2) Subjects who shows 21 or more scores in HDS-R.
Key exclusion criteria
1) Subjects who have been diagnosed with dementia or suspected of dementia.
2) Subjects who have been suspected of mental disorders such as schizophrenia and depression.
3) Subjects who have serious disease or medical history in brain, liver, kidney, heart, lung, gastrointestinal tract, blood, or endocrine metabolism, etc.
4) Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
5) Subjects who have a medical history of serious allergy to medicine and food.
6) Subjects who are judged unsuitable for participating in this study by doctors.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsunaga Miyasaka |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
mjc-m.miyasaka@matsutan.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Shimamura |
Organization
Matsumoto Health Lab
Division name
None
Zip code
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
shimamura@m-health-lab.jp
Sponsor or person
Institute
Matsumoto Junior College
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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 | 04 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC7266326/
Number of participants that the trial has enrolled
268
Results
Naoki Yuda, Miyuki Tanaka, Koji Yamauchi, Fumiaki Abe, Izumi Kakiuchi, Kyoko Kiyosawa, Mitsunaga Miyasaka, Naoki Sakane, Masahiko Nakamura
Effect of the Casein-Derived Peptide Met-Lys-Pro on Cognitive Function in Community-Dwelling Adults Without Dementia: A Randomized, Double-Blind, Placebo-Controlled Trial
Clin Interv Aging. 2020 May 27:15:743-754.
Results date posted
| 2024 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
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
| 2018 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | 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 | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037442
