UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062917 |
|---|---|
| Receipt number | R000072033 |
| Scientific Title | Effects of Chewing and Cognitive Tasks During Aerobic Exercise on Prefrontal Cortex Activity |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/14 15:05:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Chewing and Cognitive Tasks During Aerobic Exercise on Prefrontal Cortex Activ
Acronym
Effects of Chewing and Cognitive Tasks During Aerobic Exercise on Prefrontal Cortex Activ
Scientific Title
Effects of Chewing and Cognitive Tasks During Aerobic Exercise on Prefrontal Cortex Activity
Scientific Title:Acronym
Effects of Chewing and Cognitive Tasks During Aerobic Exercise on Prefrontal Cortex Activ
Region
| Japan |
Condition
Condition
Cognitive decline
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of chewing and cognitive tasks on prefrontal cortex activity during aerobic exercise.
Basic objectives2
Others
Basic objectives -Others
Evaluation of physiological and neuropsychological responses to the combination of chewing, cognitive tasks, and aerobic exercise.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in prefrontal cortex total hemoglobin concentration measured by near-infrared spectroscopy (NIRS) under each experimental condition.
Key secondary outcomes
Heart rate variability, electroencephalographic activity, electrodermal activity, salivary amylase concentration, and psychological state assessed using the Two-Dimensional Mood Scale.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants will perform gum chewing alone
Interventions/Control_2
Participants will perform aerobic exercise alone.
Interventions/Control_3
Participants will perform aerobic exercise combined with gum chewing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults without subjective or objective systemic or stomatognathic abnormalities and without a history or current diagnosis of neurosurgical disease. Participants will be athletes, coaches, or staff members of universities or private sports clubs supported by the research group, who provide written informed consent.
Key exclusion criteria
Individuals with cardiovascular, respiratory, orthopedic, neurological, or psychiatric disorders that may interfere with exercise or cognitive tasks.
Individuals with oral diseases that may interfere with chewing, speaking, or exercise.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Nakajima |
Organization
Tokyo Dental College
Division name
Division of Sports Dentistry, Department of Oral Health and Clinical Science
Zip code
101-0061
Address
2-9-18 Kanda-Misakicho, Chiyoda-ku, Japan
TEL
03-6380-9177
knakaji@tdc.ac.jp
Public contact
Name of contact person
| 1st name | kazunori |
| Middle name | |
| Last name | nakajima |
Organization
Tokyo Dental College
Division name
Division of Sports Dentistry, Department of Oral Health and Clinical Science
Zip code
101-0061
Address
2-9-18 Kanda-Misakicho, Chiyoda-ku, Japan
TEL
03-6380-9177
Homepage URL
knakaji@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), KAKENHI
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
Tel
03-6380-9114
drinri@tdc.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
| 2026 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072033
