Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059432) titled 'Performance Evaluation of Cooling Wear in a Hot Environment' on Oct. 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 subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Investigating the influence of workwear designed to mitigate heat stress on core body temperature during physical exertion in a hot environment Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Wearing a garment with an active cooling function (Design 1) Interventions/Control_2 - Wearing a garment with an active cooling function (Design 2)

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - ･Healthy males aged 18 to 45 years, inclusive, at the time of providing informed consent, with no history of serious medical conditions and in good physical and mental health. ･Individuals with a Body Mass Index (BMI) ranging from 18.5 to 25.0 kg/m2. ･Individuals who engage in regular physical exercise at least twice a week. ･Individuals who are capable of providing voluntary written informed consent after receiving a full explanation of the study's purpose, procedures, and potential benefits and risks, and who have understood the information. Key exclusion criteria - ･Individuals who are currently receiving treatment for any medical condition or have a history of serious diseases requiring medication (e.g., cardiovascular, respiratory, or metabolic diseases). ･Individuals with a history of severe heat illness (Grade II or higher) diagnosed by a physician. ･Individuals with a physician-diagnosed history of vasovagal reflex. ･Individuals who have previously lost consciousness after exercise. ･Individuals with orthopedic conditions (such as lower back pain or knee pain) or a history of trauma that could interfere with performing the cycling exercise. ･Individuals who regularly take medications or supplements known to affect thermoregulation, cardiovascular function, or metabolism. ･Individuals who are current smokers. ･Individuals with skin conditions that would interfere with the attachment of monitoring equipment or who have known allergies to the materials being used. ･Individuals deemed unsuitable for participation by the principal investigator or study physician for any reason, including health status or safety concerns. Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 16 Day Date of IRB - 2025 Year 10 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067959

Disclaimer: Curated by HT Syndication.