UMIN-CTR Clinical Trial

Basic information
Public title	The effect of milk beverage intake on brain activity
Acronym	The effect of milk beverage intake on brain activity
Scientific Title	The effect of milk beverage intake on brain activity
Scientific Title:Acronym	The effect of milk beverage intake on brain activity
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 beverage with placebo beverage on brain activity during cognitive task in healthy subjects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in oxygenated hemoglobin concentration during cognitive task
Key secondary outcomes	The changes in deoxygenated and total hemoglobin concentration during cognitive task and the scores of the Uchida-Kraepelin test

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of milk beverage(176kcal)-> Washout more than 2days-> Single ingestion of placebo beverage(176kcal)
Interventions/Control_2	Single ingestion of placebo beverage(176kcal)-> Washout more than 2days-> Single ingestion of milk beverage(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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects who have given written informed consent 2)Employees of Meiji Co., Ltd. 3)Healthy subjects aged 20 to 40 years old 4)Subjects who are right-handed
Key exclusion criteria	1)Subjects with wheat, milk, chicken, pork, beef, soybeans, apples or gelatin allergies 2)Subjects who are using devices which are affected by magnetic fields(e.g. cochlear implants and pacemakers). 3)Subjects who have had serious head injuries or central nervous system diseases. 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 medical doctor or lead principal investigator for other reasons
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Middle name Last name Okaya Eiji
Organization	Meiji Co., Ltd.
Division name	Food science & Technology Research Laboratories, R&D Division
Zip code
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL	042-632-5849
Email	eiji.okaya@meiji.com

Public contact
Name of contact person	1st name Middle name Last name Yamaguchi Makoto
Organization	Meiji Co., Ltd.
Division name	Food science & Technology Research Laboratories, R&D Division
Zip code
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL	042-632-5849
Homepage URL
Email	makoto.yamaguchi@meiji.com

Sponsor
Institute	Meiji Co., Ltd
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	株式会社 明治　研究本部/ R&D Division, Meiji Co., Ltd.

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 25 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	Completed
Date of protocol fixation	2018 Year 01 Month 24 Day
Date of IRB	2018 Year 01 Month 24 Day
Anticipated trial start date	2018 Year 01 Month 25 Day
Last follow-up date	2018 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2020 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035396