UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neural basis of appetite control and development of methods to help appetite control
Title of the study (Brief title)	Neural basis and methods of appetite control
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understanding neural basis of appetite control and developing methods to help appetite control
Basic objectives2	Others
Basic objectives -Others	Basic natural science
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Regional brain activities correlated to success/failure of appetite control
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	cognitive strategies and neurofeedback
Interventions/Control_2	cognitive strategies
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 and Female
Key inclusion criteria	Healthy university students
Key exclusion criteria	MRI contraindication Auditory inability left handedness Past history of neurological illness Dietary restrictions
Target sample size	40

Research contact person
Name of lead principal investigator	Ryuta Kawashima
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Address	Seiryo-machi 4-1, Aoba-ku, Sendai 980-8575
TEL	022-717-7988
Email	fbi@idac.tohoku.ac.jp

Public contact
Name of contact person	Takayuki Nozawa
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Address	Seiryo-machi 4-1, Aoba-ku, Sendai 980-8575
TEL	022-717-7988
Homepage URL
Email	takayuki.nozawa.b5@tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 02 Day
Anticipated trial start date	2016 Year 01 Month 05 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	2015 Year 12 Month 22 Day
Last modified on	2016 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023452