UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042707 |
|---|---|
| Receipt number | R000048746 |
| Scientific Title | Relationship between sensory processing sensitivity and eating behavior |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2021/12/13 07:30:47 |
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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
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
satoshi.takasugi@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048746
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
