Healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core temperature (rectal temperature) | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin temperature (chest, upper arm, thigh) Tympanic temperature Sweat rate Heart rate Heart rate variability (HRV) Body weight Thermal sensation Thermal comfort Rating of Perceived Exertion (RPE) | — |
Countries
Japan
Contacts
EUPHORIA Co., Ltd. Corporate Business Division