UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050151 |
|---|---|
| Receipt number | R000057086 |
| Scientific Title | L-menthol influence on discomfort perception of breathing during endurance exercise |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2025/02/26 14:20:06 |
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Basic information
Public title
L-menthol influence on discomfort perception of breathing during endurance exercise
Acronym
L-menthol influence on discomfort perception of breathing during endurance exercise
Scientific Title
L-menthol influence on discomfort perception of breathing during endurance exercise
Scientific Title:Acronym
L-menthol influence on discomfort perception of breathing during endurance exercise
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effect of l-menthol administration on the perception of breathing discomfort during endurance exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Breathing discomfort perception, EEG source power and network
Key secondary outcomes
endurance time, heart rate, oxygen uptake, CO2 exhalation, respiratory rate, ventilation volume, respiratory exchange ratio, subjective level of fatigue, O2 saturation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
l-menthol/water solution
Interventions/Control_2
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
| 25 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1) Healthy adult who has no limitation in bicycling
2) Running or bicycling long distance daily (4-5 days/wk)
Key exclusion criteria
1. Musculoskeletal disorder/disease
2. Metabolic diseases.
3. Respiratory diseases.
4. Acute infectious diseases.
5. Visual/auditory failure
6. Neurological disorder/disease
7. Dislike l-menthol
8. Under medication
9. claustrophobia
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-machi, 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Tsutsumi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
yoshiko@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Ryoichi Nagatomi
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo 2-1, Aoba-ku, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057086
