UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059432 |
|---|---|
| Receipt number | R000067959 |
| Scientific Title | The Influence of Workwear Designed to Mitigate Heat Stress on Core Body Temperature during Physical Activity |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/21 15:10:58 |
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Basic information
Public title
Performance Evaluation of Cooling Wear in a Hot Environment
Acronym
Performance Evaluation of Cooling Wear in a Hot Environment
Scientific Title
The Influence of Workwear Designed to Mitigate Heat Stress on Core Body Temperature during Physical Activity
Scientific Title:Acronym
Evaluation Test of Core Body Temperature Regulation during Exercise in a Hot Environment
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the influence of workwear designed to mitigate heat stress on core body temperature during physical exertion in a hot environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature (rectal temperature)
Key secondary outcomes
Skin temperature (chest, upper arm, thigh)
Tympanic temperature
Sweat rate
Heart rate
Heart rate variability (HRV)
Body weight
Thermal sensation
Thermal comfort
Rating of Perceived Exertion (RPE)
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
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing a garment with an active cooling function (Design 1)
Interventions/Control_2
Wearing a garment with an active cooling function (Design 2)
Interventions/Control_3
Wearing a control garment
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
| 46 | years-old | > |
Gender
Male
Key inclusion criteria
･Healthy males aged 18 to 45 years, inclusive, at the time of providing informed consent, with no history of serious medical conditions and in good physical and mental health.
･Individuals with a Body Mass Index (BMI) ranging from 18.5 to 25.0 kg/m2.
･Individuals who engage in regular physical exercise at least twice a week.
･Individuals who are capable of providing voluntary written informed consent after receiving a full explanation of the study's purpose, procedures, and potential benefits and risks, and who have understood the information.
Key exclusion criteria
･Individuals who are currently receiving treatment for any medical condition or have a history of serious diseases requiring medication (e.g., cardiovascular, respiratory, or metabolic diseases).
･Individuals with a history of severe heat illness (Grade II or higher) diagnosed by a physician.
･Individuals with a physician-diagnosed history of vasovagal reflex.
･Individuals who have previously lost consciousness after exercise.
･Individuals with orthopedic conditions (such as lower back pain or knee pain) or a history of trauma that could interfere with performing the cycling exercise.
･Individuals who regularly take medications or supplements known to affect thermoregulation, cardiovascular function, or metabolism.
･Individuals who are current smokers.
･Individuals with skin conditions that would interfere with the attachment of monitoring equipment or who have known allergies to the materials being used.
･Individuals deemed unsuitable for participation by the principal investigator or study physician for any reason, including health status or safety concerns.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
ryosuke.takahashi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYOSHIMA & CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 10 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067959
