UMIN-CTR Clinical Trial

Basic information
Public title	Acute benefits of milk protein drink on cognition
Acronym	Acute benefits of milk protein drink on cognition
Scientific Title	Acute benefits of milk protein drink on cognition
Scientific Title:Acronym	Acute benefits of milk protein drink on cognition
Region	Japan

Condition
Condition	Helthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the benefits of milk protein on cognition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Calculation test
Key secondary outcomes	Raven test Japanese Reading Ability Test Stroop test memory updating digit symbol test digit symbol coding STAI: State-Trait Anxiety Inventory WHO-Five well-being index General Health Questionnaire 12 CES-D: center for epidemiologic studies depression scale sleep questionnaire brief-type self-administered diet history questionnaire physical activity scale Ten Item Personality Inventory Effort ful control scale Profile of Mood States 2 Two-dimensional Mood Scale-Short Term VAS rating for taste and sweetness blood sugar

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Intaking 15g milk protein drink
Interventions/Control_2	Intaking 10g milk protein drink
Interventions/Control_3	Intaking no milk protein drink (control drink)
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	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese Speaker right-handed a person who can do dietary restrictions
Key exclusion criteria	We will exclude the subjects with a mental disorder, diabetes, cranial nerve disease, cardiac disease, pregnant, dialysis, pacemaker, and food allergy. In addition, a person who is a heavy alcohol drinker and participated in another intervention study within 1 month.
Target sample size	66

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryuta Kawashima
Organization	Tohoku University
Division name	Department of functional brain imaging
Zip code
Address	Sendai, seiryo4-1
TEL	022-717-7988
Email	fbi@idac.tohoku.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Rui Nouchi
Organization	Tohoku Univeristy
Division name	Department of cognitive health science
Zip code
Address	Sendai, seiryo4-1
TEL	022-717-8952
Homepage URL
Email	rui@tohoku.ac.jp

Sponsor
Institute	Tohoku Universiry
Institute
Department

Funding Source
Organization	Meiji
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	2019 Year 02 Month 07 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	Preinitiation
Date of protocol fixation	2018 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 07 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040778

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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