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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035796
Receipt No. R000040778
Official scientific title of the study Acute benefits of milk protein drink on cognition
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/07

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Basic information
Official scientific title of the study Acute benefits of milk protein drink on cognition
Title of the study (Brief title) 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
Name of lead principal investigator Ryuta Kawashima
Organization Tohoku University
Division name Department of functional brain imaging
Address Sendai, seiryo4-1
TEL 022-717-7988
Email fbi@idac.tohoku.ac.jp

Public contact
Name of contact person Rui Nouchi
Organization Tohoku Univeristy
Division name Department of cognitive health science
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 18 Day
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

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Publication of results Unpublished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