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 2019/06/19 10:52:48

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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

Email

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


Email

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


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

2018 Year 06 Month 04 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

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

2019 Year 06 Month 19 Day



Link to view the page

Value
https://center6.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