Tokyo, Dec. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059955) titled 'Evaluation of internal body cooling in workplace' on Dec. 3.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Ice slurry ingestion
Interventions/Control_2 - Control beverage ingestion
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 Size - 10
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064665
Disclaimer: Curated by HT Syndication.