UMIN-CTR Clinical Trial

Basic information
Public title	Magnetoencephalographic study on neural basis of motivation to eat
Acronym	Magnetoencephalographic study on motivation to eat
Scientific Title	Magnetoencephalographic study on neural basis of motivation to eat
Scientific Title:Acronym	Magnetoencephalographic study on motivation to eat
Region	Japan

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

Objectives
Narrative objectives1	The present study aims to elucidate the neural mechanisms of motivation to eat by examining the neural activities when healthy adults are motivated to eat food by magnetoencephalography(MEG).
Basic objectives2	Others
Basic objectives -Others	To elucidate neural mechanisms related to motivation to eat in healthy adults by magnetoencephalography(MEG).
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	MEG data
Key secondary outcomes	Questionnaires, Electrocardiography (ECG)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Main session (food pictures)-1, Control session(mosaic images)-1, Main session (food pictures)-2, Control session(mosaic images)-2
Interventions/Control_2	Control session(mosaic images)-1, Main session (food pictures)-1, Control session(mosaic images)-2, Main session (food pictures)-2,
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Participants with past or current history of serious medical illness and/or brain organic disease, who take central nerve system acting drugs, who are contradicted for the use of MRI, and who are judged as not suitable for participation in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports medicine
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3790
Email	tkhr6719@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports medicine
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3790
Homepage URL
Email	tkhr6719@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Foundation for Total Health Promotion.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics Committee of Osaka City University Graduate School of Medicine
Address	1-2-7, Asahi-machi, Abeno-ku, Osaka, 545-8533
Tel	06-6645-3435
Email	ethics@med.osaka-cu.ac.jp

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	大阪市立大学医学部附属病院（大阪）, Osaka City University Hospital (Osaka)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 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	2017 Year 09 Month 30 Day
Date of IRB	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2018 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 02 Day
Last modified on	2019 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034055