UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between sensory processing sensitivity and eating behavior
Acronym	Relationship between sensory processing sensitivity and eating behavior
Scientific Title	Relationship between sensory processing sensitivity and eating behavior
Scientific Title:Acronym	Relationship between sensory processing sensitivity and eating behavior
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate in adults living in Japan the relationship between sensory processing sensitivity assessed by the Japanese version of the 19-item Highly Sensitive Person Scale (HSPS-J19) and eating behavior index assessed by Food Choice Questionnaire (FCQ) etc.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between the results of HSPS-J19 and FCQ.
Key secondary outcomes	Relationship between the results of HSPS-J19 and some scales (Food Addiction Scale, Gastrointestinal Symptom Rating Scale, Food Frequency Questionnaire, and taste preferences). Relationship between these scales.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Adults aged 20-39, living in Japan (excluding students)
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Takasugi
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan
TEL	+81-42-632-5810
Email	satoshi.takasugi@meiji.com

Public contact
Name of contact person	1st name Satoshi Middle name Last name Takasugi
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL	+81-42-632-5810
Homepage URL
Email	satoshi.takasugi@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Self-financing
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	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel	+81-42-632-5900
Email	MEIJI.IRB@meiji.com

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	2020 Year 12 Month 23 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	863
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	2020 Year 10 Month 14 Day
Date of IRB	2020 Year 10 Month 14 Day
Anticipated trial start date	2020 Year 12 Month 23 Day
Last follow-up date	2020 Year 12 Month 24 Day
Date of closure to data entry	2020 Year 12 Month 24 Day
Date trial data considered complete	2021 Year 01 Month 21 Day
Date analysis concluded	2021 Year 10 Month 26 Day

Other
Other related information	HSPS-J19, FCQ, GSRS, Food Addiction Scale, Gastrointestinal Symptom Rating Scale, Food Frequency Questionnaire, and taste preferences etc. will be measured by online survey system.

Management information
Registered date	2020 Year 12 Month 10 Day
Last modified on	2021 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048746