UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060156 |
|---|---|
| Receipt number | R000068801 |
| Scientific Title | Elucidation of Molecular Mechanisms Underlying Exercise-Induced Mood Improvement Using a Human Knockout Model |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/12/22 10:37:20 |
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Basic information
Public title
Elucidation of Molecular Mechanisms Underlying Exercise-Induced Mood Improvement Using a Human Knockout Model
Acronym
Elucidation of Molecular Mechanisms Underlying Exercise-Induced Mood Improvement Using a Human Knockout Model
Scientific Title
Elucidation of Molecular Mechanisms Underlying Exercise-Induced Mood Improvement Using a Human Knockout Model
Scientific Title:Acronym
Elucidation of Molecular Mechanisms Underlying Exercise-Induced Mood Improvement Using a Human Knockout Model
Region
| Japan | Europe |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study biochemically investigates whether endocannabinoids (eCBs) mediate acute exercise-induced mood improvement, utilizing a human knockout model based on gene expression capacity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma endocannabinoid concentrations (pre- and post-intervention)
Key secondary outcomes
Gene polymorphisms (CNR1, FAAH; baseline)
Lifestyle habits (Food Frequency Questionnaire, Pittsburgh Sleep Quality Index, International Physical Activity Questionnaire; baseline)
Heart rate (During intervention)
Rating of Perceived Exertion (During intervention)
Mood states (Physical Activity Affect Scale, Positive and Negative Affect Schedule; Pre- and post-intervention)
mRNA expression levels (CB1R, FAAH; baseline)
Activity levels (CB1R, FAAH; baseline)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will perform cycle ergometer exercise at 40% heart rate reserve for 30 minutes in the exercise condition, and maintain a resting state for 30 minutes in the control condition.
Interventions/Control_2
Magnetic resonance spectroscopy (MRS) will be performed after the intervention. During the MRS acquisition, mood fluctuations will be induced using the Open Affective Standardized Image Set (OASIS).
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Untrained individuals
Key exclusion criteria
Individuals with abnormal findings in medical check-ups.
Individuals currently taking medication.
Current smokers.
Individuals unable to perform exercise at the prescribed intensity.
Individuals with a history of vasovagal reflex (fainting) during blood sampling.
Target sample size
60
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
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University College London
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
kakenhi@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
| 2025 | Year | 12 | Month | 31 | 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
| 2025 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068801
