UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035796
Receipt number R000040778
Scientific Title Acute benefits of milk protein drink on cognition
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/07 09:07:33

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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

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

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 or person

Institute

Tohoku Universiry

Institute

Department

Personal name



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

Value
https://center6.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