UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of milk protein intake on cognitive performance in the morning
Title of the study (Brief title)	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	Urashima Tadasu
Organization	Obihiro University of Agriculture and Veterinary Medicine
Division name	Department of Animal and Food Hygiene
Address	Nishi2sen 11banchi, Inada cho, Obihiro, Hokkaido
TEL	0155-49-5566
Email	urashima@obihiro.ac.jp

Public contact
Name of contact person	Teruyuki Noma
Organization	Meiji Co., Ltd
Division name	Functional Evaluation Drepartment1 Food Science Research Laboratories R&D Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.mdpi.com/2072-6643/10/5/574
Results
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/icdr_e/ctr_view.cgi?recptno=R000026931