UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study regarding the effects of unconscious neural activity on lifestyle habit
Title of the study (Brief title)	A study regarding the effects of unconscious neural activity on lifestyle habit
Region	Japan

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

Objectives
Narrative objectives1	To clarify the mechanisms of unconscious neural responses to visual food stimuli.
Basic objectives2	Others
Basic objectives -Others	Investigating the neural mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The MEG data
Key secondary outcomes	Questionnaires and autonomic activity

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	Cognitive task1, Congnitive task 2
Interventions/Control_2	Congnitive task 2, Cognitive task1
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	60 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 unsuitable for participation in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiro Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
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	Takahiro Yoshikawa
Organization	Osaka City University Graduate School of Medicine
Division name	Sports Medicine
Address	1-4-3,Asahi-machi,Abeno-ku,Osaka, 545-8585
TEL	06-6645-3790
Homepage URL	http://www.med.osaka-cu.ac.jp/sportsmed/
Email	tkhr6719@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
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)

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 03 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 23 Day
Anticipated trial start date	2017 Year 03 Month 13 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 07 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030367