UMIN-CTR Clinical Trial

Basic information
Public title	Neural representations of the sensation and value of carbonation and sweetness
Acronym	carbonation and sweetness fMRI
Scientific Title	Neural representations of the sensation and value of carbonation and sweetness
Scientific Title:Acronym	carbonation and sweetness fMRI
Region	Japan

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

Objectives
Narrative objectives1	To reveal the neural representation of the sensation and value of carbonation and sweetness
Basic objectives2	Others
Basic objectives -Others	cognitive neuroscience
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BOLD signal changes correlated with the sensation and value of the carbonated or sweetened water
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	drink (sweetened/carbonated)
Interventions/Control_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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy undergraduate pr graduate students
Key exclusion criteria	MRI incompatible cannot drink carbonated water history of psychiatric disease left-handed
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motoaki Sugiura
Organization	Tohoku University
Division name	IDAC
Zip code
Address	Seiryo-cho 4-1, Aoba-ku, Sendai
TEL	022-717-8563
Email	sugiura@tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Motoaki Sugiura
Organization	Tohoku University
Division name	IDAC
Zip code
Address	Seiryo-cho 4-1, Aoba-ku, Sendai
TEL	022-717-8563
Homepage URL
Email	sugiura@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 02 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 10 Month 31 Day
Date of IRB	2017 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2022 Year 05 Month 26 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	2022 Year 05 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034053