Time Onset Sweat Sodium (TOSS) Study (TOSS)

March 9, 2026 updated by: Brendon P. McDermott, University of Arkansas, Fayetteville
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Short trial (30min exercise in the heat)
Short trial. We will assess sweat rate and sweat-sodium losses during exercise in the heat.
Other: Exercise in the heat
Our trials will be conducted in an environmental chamber set to 80-100 degrees F and 40-60 relative humidity.
Other: Long trials (120min exercise in the heat)
Long trial. we will assess sweat rate and sweat-sodium losses during exercise in the heat. We will also determine if 30min exercise trials accurately predict fluid and Na losses during 120min exercise in the heat.
Other: Exercise in the heat
Our trials will be conducted in an environmental chamber set to 80-100 degrees F and 40-60 relative humidity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0-30min; 30-60min; 60-90min; 90-120min - Every 30min during exercise in the heat
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.
Every 30min during trails with exercise in the heat.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas, Fayetteville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2509625720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified data will be available through clinicaltrials.gov and reasonable requests made to corresponding authors once manuscripts have been submitted for publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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