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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023373
Receipt No. R000026931
Scientific Title The effects of milk protein intake on cognitive performance in the morning
Date of disclosure of the study information 2016/12/01
Last modified on 2018/07/27

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Basic information
Public title The effects of milk protein intake on cognitive performance in the morning
Acronym The effects of milk protein intake on cognitive performance in the morning
Scientific Title The effects of milk protein intake on cognitive performance in the morning
Scientific Title:Acronym The effects of milk protein intake on cognitive performance in the morning
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of milk protein containing drink with placebo drink on cognitive performance in the morning in healthy subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The scores of the Uchida-Kraepelin test after single ingestion of milk protein containing drink or placebo drink
Key secondary outcomes The scores of the Stroop test, subjective symptoms measured by VAS(visual analogue scale), body temperature, heart rate variability after single ingestion of milk protein containing drink or placebo drink

Base
Study type Interventional

Study design
Basic design Cross-over
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 Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of milk protein containing drink(176kcal)-> Washout more than 2days-> Single ingestion of placebo drink(176kcal)
Interventions/Control_2 Single ingestion of placebo drink(176kcal)-> Washout more than 2days-> Single ingestion of milk protein containing drink(176kcal)
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
18 years-old <=
Age-upper limit
30 years-old >
Gender Male
Key inclusion criteria 1)Subjects who have given written informed consent
2)Healthy males aged 18 to 30 years old
Key exclusion criteria 1)Subjects with milk or soy allergies
2)Subjects with serious or progressive illnesses
3)Subjects who have difficulty in
distinguishing between reds, blues, greens and yellows
4)Subjects who have been regularly taking drugs, quasi drugs, health foods or supplements that may affect this study within 3 months prior to the start of this study
5)Subjects who have participated in other clinical studies within 1 month prior to the start of this study
6)Subjects who are judged as ineligible by the doctor or lead principal investigator for other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Urashima Tadasu
Organization Obihiro University of Agriculture and Veterinary Medicine
Division name Department of Animal and Food Hygiene
Zip code
Address Nishi2sen 11banchi, Inada cho, Obihiro, Hokkaido
TEL 0155-49-5566
Email urashima@obihiro.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruyuki Noma
Organization Meiji Co., Ltd
Division name Functional Evaluation Drepartment1 Food Science Research Laboratories R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa, Japan
TEL 0465-37-3654
Homepage URL
Email teruyuki.noma@meiji.com

Sponsor
Institute Meiji Co., Ltd
Institute
Department

Funding Source
Organization Meiji 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 帯広畜産大学(北海道)/Obihiro University of Agriculture and Veterinary Medicine(Hokkaido)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.mdpi.com/2072-6643/10/5/574
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
2016 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 02 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
2016 Year 07 Month 28 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026931

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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