UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057487 |
|---|---|
| Receipt number | R000065689 |
| Scientific Title | Effect of body cooling on core temperature in a hot environment |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 12:08:53 |
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Basic information
Public title
Effect of body cooling on core temperature in a hot environment
Acronym
Effect of body cooling on core temperature in a hot environment
Scientific Title
Effect of body cooling on core temperature in a hot environment
Scientific Title:Acronym
Effect of body cooling on core temperature in a hot environment
Region
| Japan |
Condition
Condition
Hot environment
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effect of body cooling on deep body temperature in a hot environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control group (no cooling: CON)
Interventions/Control_2
Resting in a cool place (Passive Cooling, PC)
Interventions/Control_3
PC with Palm cooling (Active Cooling, AC) (PCAC)
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
| 64 | years-old | > |
Gender
Male
Key inclusion criteria
1 Individuals aged 18 to 64 years who have freely and voluntarily provided written informed consent after receiving and fully understanding a detailed explanation of the study's purpose and content.
2 Healthy adult males with no current medical conditions under treatment. To eliminate the influence of menstruation and female hormones, only male participants will be included.
3 Non-smokers.
Key exclusion criteria
1 Individuals with lifestyle-related diseases such as hypertension, diabetes, or dyslipidemia.
2 Individuals with a history of cardiovascular, metabolic, or neurological diseases who are deemed at risk for exercise or activities in hot environments.
3 Individuals with a history of heatstroke within the past six months that may affect their participation in the study under hot conditions.
4 Individuals deemed unsuitable as study participants by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Higaki |
Organization
Fukuoka university
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
19-1, Nanakuma, Jonaku, Fukuokacity, Fukuoka, Japan
TEL
092-871-6631
higaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Tomiga-Takae |
Organization
Fukuoka university
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonaku, Fukuokacity, Fukuoka, Japan
TEL
092-871-6631
Homepage URL
lrietty.tl@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
pending
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
Fukuoka Univ. Department of Bioethics & Medical Ethics
Address
8-19-1, Nanakuma, Jonaku, Fukuokacity, Fukuoka, Japan, 814-0180
Tel
092-801-1011 (Ext. 3193)
fumed-ethics@fukuoka-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 02 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065689
