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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032833
Receipt No. R000037442
Official scientific title of the study 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 2018/07/26

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Basic information
Official scientific title of the study Study of the effects of casein-derived peptides on cognitive function -A randomized, double-blind, placebo-controlled, parallel-group study-
Title of the study (Brief title) 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 Mitsunaga Miyasaka
Organization Matsumoto Junior College
Division name Department of Nursing
Address 3118, Sasaga, Matsumoto, Nagano, Japan
TEL 0263-58-4417
Email mjc-m.miyasaka@matsutan.ac.jp

Public contact
Name of contact person Akira Shimamura
Organization Matsumoto Health Lab
Division name None
Address M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL 0263-39-1139
Homepage URL
Email shimamura@m-health-lab.jp

Sponsor
Institute Matsumoto Junior College
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 16 Day
Anticipated trial start date
2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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