UMIN-CTR Clinical Trial

Basic information
Public title	Effect of eating with eye image on deliciousness
Acronym	Effect of eating with eye image on deliciousness
Scientific Title	Effect of eating with eye image on deliciousness
Scientific Title:Acronym	Effect of eating with eye image on deliciousness
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine whether eating in the presence of a pseudo-other changes the deliciousness.
Basic objectives2	Others
Basic objectives -Others	Measuring subjective evaluation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of deliciousness in each condition.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Eat in the condition A.
Interventions/Control_2	Eat in the condition B.
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	22 years-old >=
Gender	Female
Key inclusion criteria	Participants are healthy students who agreed with study.
Key exclusion criteria	1) Unhealthy 2) Those who are allergic to the food used. 3) Those who request to withdraw.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Misaki Middle name Last name Kaiwa
Organization	Niigata University of Health and Welfare
Division name	Graduate school Health and Welfare
Zip code	9503198
Address	1398, Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL	025-257-4455
Email	hwd20003@nuhw.ac.jp

Public contact
Name of contact person	1st name Misaki Middle name Last name Kaiwa
Organization	Niigata University of Health and Welfare
Division name	Graduate school Health and Welfare
Zip code	9503198
Address	1398, Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL	025-257-4455
Homepage URL
Email	hwd20003@nuhw.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization	Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Niigata University of Health and Welfare Ethics Review Committee
Address	1398, Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel	025-257-4455
Email	rinri@nuhw.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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 30 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	24
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 12 Month 24 Day
Date of IRB	2019 Year 02 Month 12 Day
Anticipated trial start date	2019 Year 02 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 07 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052152