Tokyo, June 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061936) titled 'Effects of wearing functional garments for heat stress mitigation on thermal stress under different WBGT conditions' on June 17.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - EUPHORIA Co., Ltd.
Condition:
Condition - Healthy male
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Test wear
Interventions/Control_2 - Control wear
Eligibility:
Age-lower limit - 18
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 Size - 8
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070865
Disclaimer: Curated by HT Syndication.