UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054346 |
|---|---|
| Receipt number | R000061295 |
| Scientific Title | Neural effects of mental fatigue on appetite: a magnetoencephalography study |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/06/02 14:18:17 |
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Basic information
Public title
Examination of brain activity related to mental fatigue and appetite
Acronym
Examination of brain activity related to mental fatigue and appetite
Scientific Title
Neural effects of mental fatigue on appetite: a magnetoencephalography study
Scientific Title:Acronym
Neural effects of mental fatigue on appetite: a magnetoencephalography study
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of mental fatigue on appetite and the neural mechanisms.
Basic objectives2
Others
Basic objectives -Others
Investigation of the neural mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The data of magnetoencephalography (MEG); The visual analogue scale (VAS) of fatigue and appetite; The autonomic neural activity; The cognitive performance
Key secondary outcomes
The data of Questionnaires (fatigue, eating behaviors, and physical activity)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Cognitive task 1, Cognitive task 2
Interventions/Control_2
Cognitive task 2, Cognitive task1
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 adults
Key exclusion criteria
Participants with past or current history of serious medical illness including brain organic disease, visual impairment, and psychological disorders; those who take central nerve system acting drugs; those who are contradicted for the use of MRI; those who are smokers; those who are unsuitable for participating in this study.
Target sample size
25
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, 545-8585
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, 545-8585
TEL
06-6645-3790
Homepage URL
https://www.omu.ac.jp/med/sportsmed/
tkhr6719@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
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
| 2024 | Year | 08 | Month | 01 | 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
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061295
