UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060624 |
|---|---|
| Receipt number | R000069342 |
| Scientific Title | Effect of social interaction during self-paced running on the endocannabinoid system, fatigue, and negative affect |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/09 14:31:21 |
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Basic information
Public title
Effect of social interaction during self-paced running on the endocannabinoid system, fatigue, and negative affect
Acronym
Effect of social interaction during self-paced running on the endocannabinoid system, fatigue, and negative affect
Scientific Title
Effect of social interaction during self-paced running on the endocannabinoid system, fatigue, and negative affect
Scientific Title:Acronym
Effect of social interaction during self-paced running on the endocannabinoid system, fatigue, and negative affect
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how social interaction during self-paced running modulates exercise-induced mood changes and to determine whether the endocannabinoid system mediates these psychological alterations.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma endocannabinoid concentrations (pre- and post-intervention)
Key secondary outcomes
Heart rate
Rating of perceived exertion
Mood index (Physical Activity Affect 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 considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
20-min single rest
Interventions/Control_2
20-min paired rest
Interventions/Control_3
20-min single running
Interventions/Control_4
20-min paired running
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
| 22 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adults
Key exclusion criteria
People with abnormal items in health checks.
People who take any kind of medication
Smokers
People who cannot conduct exercise at the intensity set in this study.
People who have ever lost consciousness during blood sampling.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yabe |
Organization
Yamanashi Gakuin University
Division name
Faculty of Sport Science
Zip code
400-8575
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
TEL
055-224-1377
yabe.tetsuya@c2c.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yabe |
Organization
Yamanashi Gakuin University
Division name
Faculty of Sport Science
Zip code
400-8575
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
TEL
055-224-1377
Homepage URL
yabe.tetsuya@c2c.ac.jp
Sponsor or person
Institute
Yamanashi Gakuin University
Institute
Department
Personal name
Tetsuya Yabe
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Yamanashi Gakuin University
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
Tel
055-224-1234
academicaffairs@c2c.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 | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://unipa.ygu.ac.jp/kgResult/japanese/researchersHtml/yabe.tetsuya/yabe.tetsuya_Researcher.html
Publication of results
Unpublished
Result
URL related to results and publications
https://unipa.ygu.ac.jp/kgResult/japanese/researchersHtml/yabe.tetsuya/yabe.tetsuya_Researcher.html
Number of participants that the trial has enrolled
12
Results
Paired running attenuated the exercise-induced increase in fatigue and the reduction in plasma AEA levels. AEA was identified as a moderator buffering the fatigue-induced deterioration of negative affect; notably, this adverse association was significantly mitigated in high AEA responders.
Results date posted
| 2026 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were healthy non-smokers with no history of abnormalities in medical examinations, current medication use, or vasovagal syncope during blood sampling. The physical characteristics of the participants were as follows: age, 21.2 (0.4) years; height, 172.8 (6.4) cm; weight, 68.3 (9.0) kg; and body mass index (BMI), 22.9 (2.1) kg/m2 (mean [SD]).
Participant flow
A priori statistical power analysis using G*Power 3.1.9.7 indicated that a sample size of 12 was necessary to detect.
Adverse events
No adverse events were reported during the study.
Outcome measures
Plasma endocannabinoid concentrations
Heart rate
Rating of perceived exertion
Mood index (Physical Activity Affect Scale)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069342
