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NCT Number: NCT07464743

Time Onset Sweat Sodium (TOSS) Study

Prior to each trial, you will be provided with urine jugs and food/fluid logs to record food and drink intake for 24hr. You will be asked to log food/fluid intake 24hr leading into trials. We ask that you match your diet for both trials, as much as possible. Also, we ask that you match caffeine consumption prior to trials. Lastly, we ask that you refrain from strenuous exercise and alcohol consumption for at least 12hrs leading into trials. Either of these exclude your participation in the study for safety reasons. You will be asked to provide a small urine sample upon arrival to the lab before trials. The purpose of this is to verify hydration prior to exercise in the heat. If you are not hydrated upon arrival, you will be provided and asked to drink 16oz (a bottle) of water prior to the trial. Just prior to, and following each long trial, you will be asked to provide a small saliva sample. To do this, you will be asked to actively produce saliva and guide it into a small container. This process takes <5min. Next, you will have your nude body mass measured and you will be instrumented with a labbased sweat collection patch (large band-aid on the forearm), and the Hdrop sweat detection device on your left upper arm. The Hdrop will be synced with electronic applications (phone apps) to assure data collection. You will then self-insert a rectal thermistor ~15 cm past the anal sphincter to monitor core temperature throughout exercise (for safety purposes). You will also be fitted with a heart rate strap that goes around your chest. You will then be asked to enter the environmental chamber and exercise for 30min. This will serve as the short exercise trial aiming to assure comfort with the 120min exercise trials. Data will be collected during the short trial and comparisons will be made for the longer, 120min trials. The environmental chamber will maintain a consistent temperature (80-100 degrees F) and humidity (40 to 60 % relative humidity). You will be monitored for safety throughout exercise in all 3 trials, and you will be allowed to cycle (stationary bike) or run or walk (treadmill) at your own pace/intensity. Pace and intensity will be recorded during the first trial and attempts will be made to match exercise intensity for subsequent trials. Fluid consumption will be allowed during trials and will be matched between trials. In both trials, you will be allowed to drink for a 5min period at each 30min interval (30-35min, 60-65min and 90-95min). We will provide a sport drink of your flavor choice during exercise.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

If you agree to be in this study, you will be asked to report to our exercise science research center for three total visits (1 short trial and 2 separate trials separated by at least 4 days), and the total time commitment for this study will be approximately 7 hours. Prior to each trial, you will be provided with urine jugs and food/fluid logs to record food and drink intake for 24hr. You will be asked to log food/fluid intake 24hr leading into trials. We ask that you match your diet for both trials, as much as possible. Also, we ask that you match caffeine consumption prior to trials. Lastly, we ask that you refrain from strenuous exercise and alcohol consumption for at least 12hrs leading into trials. Either of these excludes your participation in the study for safety reasons. You will be asked to provide a small urine sample upon arrival to the lab before trials. The purpose of this is to verify hydration prior to exercise in the heat. If you are not hydrated upon arrival, you will be provided and asked to drink 16oz (a bottle) of water prior to the trial. Next, you will have your nude body mass measured, and you will be instrumented with a lab-based sweat collection patch (large band-aid on the forearm), and the Hdrop sweat detection device on your left upper arm. The Hdrop will be synced with electronic applications (phone apps) to assure data collection. You will then self-insert a rectal thermistor ~15 cm past the anal sphincter to monitor core temperature during exercise (for safety). You will also be fitted with a heart rate strap that goes around your chest. The first trial will involve only 30min of exercise. You will be asked to enter the environmental chamber and exercise for 30 minutes for the first trial. The participant will self-select the pace of the exercise (walk/run/cycle). The pace they will select is one they think they can maintain for 2 hours of exercising. If they need to adjust their pace, they will. The environmental chamber will maintain a consistent temperature (80-100 degrees F) and humidity (40-60% relative humidity). The second and third trials will be self-selected in terms of exercise intensity - participant chooses the intensity. Participants will be monitored for safety throughout exercise, and you will be allowed to cycle (stationary bike) or run or walk (treadmill) at your own pace/intensity. Pace and intensity will be recorded during the first trial. Subsequent trials will attempt to be matched for exercise intensity. The first trial is to familiarize participants with the protocol and environment to be sure they will be able to complete trials. Fluid consumption will be allowed during trials. In both long trials researchers will replace 80% of sweat rate losses with a sport drink during the trial. The other trial will be matched for fluid consumption. Prior to, and following, the last 2 (longer trials - 120min exercise), participants will be a asked to provide a saliva sample. This normally takes about 5min and is done by thinking of food and attempting to "drool" into a small container. This is for a hydration test to compare to urine samples provided at the same 2 time points (before and after long trials). Exercise trials will be stopped if you experience signs/symptoms of heat illness, get exhausted, or no longer want to continue. Following the exercise, sweat collection devices will be collected and analyzed for sweat electrolyte concentration and/or sweat rate detection. Upon completion of exercise, you will towel dry and have nude body mass measured again. All devices, heart rate strap and rectal thermistor will be returned. You will be provided fluids and snacks following exercise and be monitored for 15min. Following this, you will be allowed to leave, and you will be scheduled for your second trial. Following your second trial, you will be compensated for participation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regular exercisers
  • Otherwise healthy individuals
  • Capable of running/jogging or cycling for 120min straight

Exclusion criteria

  • Heat illness in the past 3 years
  • Taking medications that alter fluid balance or Na retention
  • Chronic conditions that contraindicate long duration exercise in the heat

Treatment and study plan

Exercise in the heat

Other

Our trials will be conducted in an environmental chamber set to 80-100 degrees F and 40-60 relative humidity.

Primary outcomes

  1. Sweat rate (L/hr)

    Time frame: 0-30min; 30-60min; 60-90min; 90-120min - Every 30min during exercise in the heat

    Sweat rate is measured as body mass changes during exercise in the heat.

  2. Sweat [Na]

    Time frame: Every 30min during trails with exercise in the heat.

    Sweat [Na] will be assessed via sweat patches applied during exercise in the heat.

Study contacts

Contact information is provided by the study sponsor or research team.

Brendon P. McDermott, PhD

CONTACT

[email protected]

14795754670

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Acronym: TOSS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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