UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059955 |
|---|---|
| Receipt number | R000064665 |
| Scientific Title | Evaluation of internal body cooling in workplace |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/12/03 11:11:20 |
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Basic information
Public title
Evaluation of internal body cooling in workplace
Acronym
Evaluation of internal body cooling in workplace
Scientific Title
Evaluation of internal body cooling in workplace
Scientific Title:Acronym
Evaluation of internal body cooling in workplace
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ice slurry ingestion on thermoregulatory responses and work performance in a hot environment that simulates workplace.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Physiological indices: rectal temperature, tympanic temperature, skin temperature, heart rate, body mass
2. Subjective indices: rating of perceived exertion, thermal sensation, thermal comfort
3. Work performance: cognitive function test, balance test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ice slurry ingestion
Interventions/Control_2
Control beverage ingestion
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Healthy individuals
2. Physically active individuals
3. Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and who have provided written informed consent.
4. Japanese males who are at least 20 years of age at the time of consent is written informed consent.
Key exclusion criteria
1. Individuals with serious disorders or a history of serious disorders of the digestive organs (including stomach and bowel resection), liver, kidney, heart, lungs, urinary/genital organs, blood, etc.
2. Individuals with inflammation or disease of the rectum who are unable to use the rectal thermistor safely.
3. Individuals with obstructive diseases of the digestive system
4. Individuals with physical or mental illness for participating this study.
5. Individuals with symptoms (fever of 37.5C or higher, respiratory symptoms, headache, malaise, taste or smell disorder, etc.) that are suspicious of COVID-19, and with a history of previous travel abroad or concentrated contact with patients within 2 weeks (14 days) prior to the registration date or within 2 weeks (14 days) prior to the intake of test meals.
6. Other individuals deemed inappropriate for the study by the Principal Investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hasegawa |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1, kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246592
hasehiro@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hasegawa |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1, kagamiyama, Higashi-Hiroshima, Hiroshima
TEL
0824246592
Homepage URL
hasehiro@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
TAISHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board in the Graduate School of Humanities and Social Sciences
Address
1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
Tel
082-424-6306
ed-ken-zai@office.hiroshima-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 | 12 | Month | 03 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064665
