UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061936 |
|---|---|
| Receipt number | R000070865 |
| Scientific Title | Effects of wearing functional garments for heat stress mitigation on thermal stress under different WBGT conditions |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/16 17:23:40 |
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Basic information
Public title
Effects of wearing functional garments for heat stress mitigation on thermal stress under different WBGT conditions
Acronym
Thermal stress relief by functional Clothing
Scientific Title
Effects of wearing functional garments for heat stress mitigation on thermal stress under different WBGT conditions
Scientific Title:Acronym
Thermal stress relief by functional Clothing
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of wearing clothing for heat countermeasures on physiological and subjective responses under multiple thermal environments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature (rectum)
Key secondary outcomes
Skin temperature (chest, upper arm, thigh)
Heart rate
Body weight
Thermal sensation
Thermal comfort
Thirst
Rating of perceived exertion
Microclimate temperature
Microclimate humidity
Environmental chamber temperature
Environmental chamber humidity
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Test wear
Interventions/Control_2
Control wear
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
| 46 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy males aged 18 to 45 years at the time of obtaining informed consent, with no history of serious illness, and in good physical and mental health.
Body Mass Index (BMI) ranging from 18.5 to 25.0.
Individuals who have a regular exercise habit of at least twice a week.
Individuals who can provide written informed consent voluntarily, after receiving a sufficient explanation and understanding the purpose, contents, and potential benefits and disadvantages of the study.
Key exclusion criteria
Individuals currently undergoing treatment for any illness, or those with a history of serious illness requiring medication therapy (e.g., cardiovascular disease, respiratory disease, metabolic disease).
Individuals with a history of severe heat stroke (Grade II or higher) diagnosed by a physician.
Individuals who have previously been diagnosed with or noted by a physician to have vasovagal reflex (vasovagal syncope).
Individuals with a history of loss of consciousness (syncope) after exercise.
Individuals with orthopedic complaints (e.g., low back pain, knee pain) or a history of trauma that may interfere with performing bicycle exercise.
Individuals routinely taking medications or supplements that affect thermoregulation, circulatory function, or metabolism.
Individuals who currently smoke.
Individuals with skin diseases that interfere with the attachment of measuring equipment, or those with allergies to the materials used in the study.
Individuals judged to be unsuitable for the study by the principal investigator or study physician due to health conditions, safety assurance, or other reasons.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Takayama |
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
fuminori.takayama@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
SUN-S 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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070865
