UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057591 |
|---|---|
| Receipt number | R000065621 |
| Scientific Title | Neural mechanisms by which chronic stress influences eating behavior: magnetoencephalography study |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/06 13:34:40 |
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Basic information
Public title
Research on neural effects of chronic stress on eating behavior
Acronym
Research on neural effects of chronic stress on eating behavior
Scientific Title
Neural mechanisms by which chronic stress influences eating behavior: magnetoencephalography study
Scientific Title:Acronym
Neural mechanisms by which chronic stress influences eating behavior: magnetoencephalography study
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the neural effects and mechanisms of chronic stress on eating behaviors
Basic objectives2
Others
Basic objectives -Others
Elucidation of the neural mechanisms
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Neural responses to visual food stimuli assessed by magnetoencephalography; Chronic stress and eating behaviors in daily life assessed by questionnaires
Key secondary outcomes
Height; Weight; Lifestyle and depressive mood induced by stress assessed by questionnaires; Autonomic activity; Arousal and valence response to visual stimuli; Physical activity (steps, time of activity, metabolic equivalents, amount of exercise, amount of energy consumed)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Motivation task, Suppression task
Interventions/Control_2
Suppression task, Motivation task
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy, right-handed volunteers
Key exclusion criteria
Volunteers with a current or past history of neurological or visual impairment, mental disorders or other serious diseases; Those taking medications regularly for any illness; Night shift workers; Current smokers; Those who are not suitable for MRI scans or measurements of magnetoencephalography
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate Schoool of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
tkhr6719@omu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate Schoool of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
Homepage URL
https://www.omu.ac.jp/med/sportsmed/
tkhr6719@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Medical Research Ethics Committee
Address
6th floor, Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
| 2025 | Year | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065621
