NIPH Clinical Trials Search

Comprehensive development of biomarkers and biological information for heat stress

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Heat Stress Disorders
Date of first enrollment	19/12/2025
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	A 45-minute exercise stress test will be conducted using an ergometer (a bicycle-type exercise machine) in an artificial climate chamber located in the Department of Hygiene and Preventive Medicine, School of Medicine, Fukushima Medical University, where the temperature and humidity will be kept constant (temperature (30-35 celcius), humidity (25-50%)). The load on the ergometer will be adjusted to keep the heart rate between 120 and 140 beats per minute. It is desirable to conduct the test under conditions of a normal working environment, but as there are limits to the humidity control function of the artificial climate chamber, the humidity will be set at 25-50%. * During exercise, subjects will wear vital sensors to measure skin temperature and heart rate over time. * Weight will be measured before and after exercise, and sweat volume will be measured from the difference in weight with the amount of water consumed. Measurement points (timing of sweat and saliva collection and physiological index measurement) 1. Baseline (15 minutes of rest before exercise load) 2. 15 minutes after exercise load begins 3. 30 minutes after exercise load begins 4. Immediately after exercise load ends (45 minutes have passed or when exercise is stopped due to subjective fatigue, etc.) * Saliva collection: Saliva is promptly collected using a sterilized dropper before the start of the test, and after 15 minutes, 30 minutes, and at the end. * Sweat collection: Saliva is promptly collected from sweating areas (inside of the forearm) using a dedicated sweat collection kit before the start of the test, and after 15 minutes, 30 minutes, and at the end. * Deep body temperature measurement: A rectal thermometer is worn before the start of the test, and the temperature is recorded at the start, 15 minutes, 30 minutes, and at the end of the test.

Outcome(s)

Primary Outcome	Proteins that showed statistically significant changes in expression (False Discovery Rate (FDR) < 0.05 and fold change > 1.5-fold or < 0.67-fold) in sweat and saliva at each time point after the start and end of exercise compared to baseline (15 minutes of rest before exercise).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 40age old
Gender	Male
Include criteria	1. Ages 18 to 40 at the time of consent 2. Healthy males 3. Individuals who have agreed to participate in this study
Exclude criteria	1. People currently receiving medical treatment for diabetes, hypertension, heart disease, or kidney failure. 2. People currently receiving medical treatment for psychiatric disorders. 3. People who have consented to their most recent health checkup and whose blood pressure (systolic blood pressure 140mmHg or diastolic blood pressure 90mmHg) or blood sugar (fasting blood sugar 110mg/dL or HbA1c 6.5%) exceeded the limit. 4. People whose doctor has advised them not to exercise.