UMIN-CTR Clinical Trial

Basic information
Public title	The effect of l-menthol on sensation of dyspnea and running performance
Acronym	Dyspnea of runners and l-menthol
Scientific Title	The effect of l-menthol on sensation of dyspnea and running performance
Scientific Title:Acronym	The effect of l-menthol on sensation of dyspnea and running performance
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to clarify if there is a difference in the threshold of dyspnea when a solution containing l-menthol was either swallowed or used for rinsing.
Basic objectives2	Others
Basic objectives -Others	In order to clarify if there is a difference in the endurance time and distance covered when a solution containing l-menthol was either swallowed or used for rinsing.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective dyspnea threshold
Key secondary outcomes	Running distance and time

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	swallowing/mouth rinsing 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	20 years-old <=
Age-upper limit	55 years-old >
Gender	Male
Key inclusion criteria	1. healthy adults 2. Running 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. Food allergy 7. Exercise not permitted from a medical institutes
Target sample size	20

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
Email	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 Shool of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-machi, 2-1, Aoba-ku, Sendai, Japan
TEL	022-717-8586
Homepage URL
Email	yoshiko@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Biomedical Engineering
Organization
Division
Category of Funding Organization	Self funding
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-machi, 2-1, Aoba-ku, Sendai, Japan
Tel	022-717-8007
Email	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	東北大学大学院医工学研究科

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 07 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	2020 Year 02 Month 06 Day
Date of IRB	2020 Year 02 Month 06 Day
Anticipated trial start date	2020 Year 02 Month 07 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 01 Month 31 Day
Date trial data considered complete	2021 Year 01 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044935