UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061645 |
|---|---|
| Receipt number | R000070534 |
| Scientific Title | Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise |
| Date of disclosure of the study information | 2026/05/21 |
| Last modified on | 2026/05/21 11:33:35 |
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Basic information
Public title
Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise
Acronym
Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise
Scientific Title
Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise
Scientific Title:Acronym
Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the nonlinear (U-shaped) relationship between lactate concentration changes in the dorsolateral prefrontal cortex (dlPFC) and executive function during incremental exercise, and to clarify whether these changes are associated with the plasma tryptophan/BCAA ratio and facial expression changes during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lactate concentration in the dorsolateral prefrontal cortex (dlPFC) measured by proton magnetic resonance spectroscopy (1H-MRS) before and after incremental exercise, and changes in executive function (reaction time and accuracy on the Flanker task).
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
ncremental exercise using a cycle ergometer. The workload is incremented by 15 W/min until the participant can no longer maintain the prescribed pedaling cadence (volitional exhaustion; typical duration 20 min). Heart rate and arterial oxygen saturation are continuously monitored during exercise, and a low-intensity cool down on the ergometer is performed immediately after.
Interventions/Control_2
Seated rest on the cycle ergometer for 20 minutes. The same equipment, posture, and time frame as the exercise condition are maintained to control for the effects of time alone without exercise.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 to 30 years who are students enrolled at Niigata University of Health and Welfare and who provide written informed consent. Participants must have no respiratory abnormalities and no contraindications to MRI examination (e.g., metallic implants, cardiac pacemakers, claustrophobia).
Key exclusion criteria
Individuals with a history of cardiovascular disease, orthopedic conditions requiring exercise restriction, neurological disorders, or any serious internal medical condition currently under treatment; and those who have been advised by a physician to restrict physical exercise.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City, 950-3198,Japan
TEL
025-257-4595
ochi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City, 950-3198,Japan
TEL
025-257-4595
Homepage URL
ochi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-City, 950-3198,Japan
Tel
025-257-4595
ochi@nuhw.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 | 05 | Month | 21 | 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
| 2026 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 21 | 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
| 2026 | Year | 05 | Month | 21 | Day |
Last modified on
| 2026 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070534
