UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055861 |
|---|---|
| Receipt number | R000063841 |
| Scientific Title | Investigation of the Relationship Between Social Isolation and Appetite: A Study on Neural Mechanisms Using Magnetoencephalography (MEG) |
| Date of disclosure of the study information | 2024/11/17 |
| Last modified on | 2025/04/18 09:03:15 |
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Basic information
Public title
The Relationship Between Social Isolation and Appetite: A Magnetoencephalography (MEG) Study on Neural Mechanisms
Acronym
Social Isolation and Appetite: MEG Study
Scientific Title
Investigation of the Relationship Between Social Isolation and Appetite: A Study on Neural Mechanisms Using Magnetoencephalography (MEG)
Scientific Title:Acronym
Social Isolation and Appetite - MEG Study
Region
| Japan |
Condition
Condition
Social Isolation
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the impact of social isolation on human appetite and its neural mechanisms by using brain imaging technology. Healthy participants will view food images while their appetite is assessed, and brain activity will be measured using magnetoencephalography (MEG).
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Magnetoencephalography (MEG) data, social isolation-related indicators (Japanese version of the Lubben Social Network Scale short version (LSNS-6), Japanese version of the UCLA Loneliness Scale (Version 3): UCLA Loneliness Scale Version 3), and the Visual Analogue Scale (VAS).
Key secondary outcomes
Survey on daily appetite and eating behavior (Three Factor Eating Questionnaire: TFEQ), Connor-Davidson Resilience Scale (CD-RISC), Japanese version of the Hospital Anxiety and Depression Scale (HAD), Positive Affect Negative Affect Schedule (PANAS), Pittsburgh Sleep Quality Index (PSQI), and Japanese version of the Salzburg Stress Eating Scale (SSES-J).
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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Presentation of food and non-food images
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 18 or older at the time of consent
2. Right-handed individuals
Key exclusion criteria
1. Individuals with current or past neurological, visual, or psychiatric disorders, or other severe diseases
2. Individuals receiving medication for any condition
3. Individuals with contraindications for MRI
4. Smokers
5. Individuals with metal present in their body (especially in the head and neck region), which could cause metal-related noise interference in magnetoencephalography
6. Individuals in peri-menopause or post-menopause, based on self-reported last menstrual cycle
7. Individuals with a history of severe medical or neurological disorders, or those with a current or past history of psychiatric disorders
8. Individuals with comorbidities such as cardiovascular disease or diabetes, or a history of weight-loss surgery or abdominal surgery
9. Individuals using medications that may affect the central nervous system, regularly taking painkillers, or those who are pregnant or breastfeeding
10. Individuals engaging in extreme vigorous exercise (continuous exercise for more than 8 hours per week)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Derong |
| Middle name | |
| Last name | Zeng |
Organization
Osaka Metropolitan University
Division name
Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan.
TEL
06-6645-3791
zeng.derong.p11@kyoto-u.jp
Public contact
Name of contact person
| 1st name | derong |
| Middle name | |
| Last name | zeng |
Organization
Osaka Metropolitan University
Division name
Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan.
TEL
06-6645-3791
Homepage URL
zeng.derong.p11@kyoto-u.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan.
Tel
06-6645-3791
zeng.derong.p11@kyoto-u.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
| 2024 | Year | 11 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063841
