UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050672 |
|---|---|
| Receipt number | R000057733 |
| Scientific Title | Investigation of selective brain cooling by spiciness-induced (oral TRPV1 activation) sweating: application to prevention of heat stroke |
| Date of disclosure of the study information | 2023/03/25 |
| Last modified on | 2023/09/22 19:07:51 |
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Basic information
Public title
Can brain cooling by sweating induced by spicy taste prevent heat stroke?
Acronym
BCSSw
Scientific Title
Investigation of selective brain cooling by spiciness-induced (oral TRPV1 activation) sweating: application to prevention of heat stroke
Scientific Title:Acronym
BCTRPV1SSw
Region
| Japan |
Condition
Condition
Heat stroke
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether brain cooling by sweating induced by spicy taste can prevent heat stroke, and to promote the development of treatment for heat stroke prevention by this mechanism
Basic objectives2
Others
Basic objectives -Others
Reactivity to taste stimulus reagents and heat stimuli, such as sweating and core temperature
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Tympanic temperature (tympanic temperature sensor)
Observed for 2 minutes after taste stimulus
Observed for 50 minutes after heat stimulus
Key secondary outcomes
# Whole body sweating distribution (Minor method: per adult, a mixture of 15 ml of iodine solution, 90 ml of anhydrous alcohol, and 10 ml of castor oil is applied to the skin with a brush, and after drying, starch powder is spread thinly and evenly. The iodo-starch reaction causes the sweating area to turn a dark purple color.)
# Local sweating rate (ventilation capsule method)
# Skin blood flow (local laser Doppler skin blood flow meter, 2D laser blood flow imager for skin blood flow distribution)
# Whole body skin temperature distribution (infrared thermography)
# Axillary temperature (skin temperature sensor)
# Heart rate variability (MemCalc/TarawaTM)
Observed for 2 minutes after taste stimulus
Observed for 50 minutes after heat stimulus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Experiment Day 1: After 50 minutes of whole-body heat stimulation (room temperature 40 degrees Celsius, relative humidity 50%), 150 mg of red pepper powder is applied to the tongue and included in the oral cavity. Two minutes later, the oral cavity is rinsed with fresh water and observed until each measured factor such as tympanic temperature returns to the same level as before spicy stimulation.
Experiment Day 2: Under neutral room temperature (25 degrees Celsius, 50% relative humidity), 150 mg of each of the various taste stimulants is applied to the tongue and included in the oral cavity. Two minutes later, the oral cavity is rinsed with fresh water and observed until each of the measured factors, including tympanic temperature, returns to pre-taste stimulation levels. The subject is then allowed to rest for 2 minutes. The next taste stimulus is then administered. The entire process is expected to take approximately 1 hour.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Persons with dermatitis or other skin diseases, facial, glossopharyngeal, or vagus nerve palsy, or sensory disorders that affect sweating.
Allergic to iodine or alcohol.
In the case where the research subject is a student at a university where the principal investigator is a faculty member, a student who has not earned the principal investigator's lecture credits to ensure that there is no educational interest.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | Sakamoto |
| Last name | Inukai |
Organization
Aichi Medical University
Division name
Department of Physiology, School of Medicine
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311ext.12272
yinukai@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | Sakamoto |
| Last name | Inukai |
Organization
Aichi Medical University
Division name
Department of Physiology, School of Medicine
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311ext.12272
Homepage URL
yinukai@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University Faculty of Medicine Ethics Committee
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561-62-3311ext.23827
amu_ethics@aichi-med-u.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
愛知医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 25 | 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
| 2023 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2033 | 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
| 2023 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057733
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