- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07490756
Methods of Assessing Sweat-Electrolyte Testing (MAST) (MAST)
March 18, 2026 updated by: Brendon P. McDermott, University of Arkansas, Fayetteville
If you agree to be in this study, you will be asked to report to our exercise science research center for two total visits (2 separate trials separated by at least 4 days) and the total time commitment for this study will be approximately 5 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 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.
Next, you will be seated, have 2 electrodes placed on your inner forearm and researchers will apply electrical stimulation for about 5min.
Typically, people feel slight tingling or nothing at all during this procedure.
This is a passive way of making you sweat on your forearm.
Sweat will then be collected via a small disc applied to your forearm.
Immediately following this, 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), a Gatorade sweat collection patch on the opposite forearm, and the Hdrop sweat detection device on your left upper arm.
the hDrop device is non-FDA approved device because it does not provide a medical diagnosis, but serves as an education and recovery tool.
These devices will all be synced with electronic applications (phone apps) to assure data collection.
You will then self-insert a rectal thermistor ~15cm 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 60min.
The environmental chamber will maintain a consistent temperature (80 degrees F) and humidity (~45% relative humidity).
You 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 and matched for the second trial.
Because fluid consumption may impair accuracy of sweat collection devices, participants will not be allowed to consume fluids during exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prior to each trial, participants will be provided with urine jugs and food/fluid logs to record food and drink intake for 24hr.
They will be asked to log food/fluid intake.
They will provide a small urine sample to verify hydration prior to exercise in the heat.
If participants arrive dehydrated, they will be provided and asked to consume 16oz (a bottle) of water.
Next, Participants will be seated, have 2 electrodes placed on their inner forearm and then get iontophoresis (direct current electrical stimulation) applied for about 5min.
This is a passive way of eliciting a local sweat response.
Sweat will then be collected via a small disc applied to their forearm.
Immediately following this, participants will have their nude body mass measured and they will be instrumented with a lab-based sweat collection patch (large band-aid on the forearm), a Gatorade sweat collection patch on the opposite forearm, and the Hdrop sweat detection device on their left upper arm.
These devices will all be synced with electronic applications (phone apps) to assure data collection.
Participants will then self-insert a rectal thermistor ~15cm past the anal sphincter to monitor core temperature throughout exercise.
They will also be fitted with a heart rate strap across their chest.
They will then enter the chamber and exercise for 60min.
The environmental chamber will maintain a consistent temperature (80 degrees F) and humidity (~45% relative humidity).
Participants will be monitored for safety throughout exercise and they will be allowed to cycle (stationary bike) or run or walk (treadmill) at their own pace/intensity.
Pace and intensity will be recorded during the first trial and matched for the second trial.
Because fluid consumption may impair accuracy of sweat collection devices, participants will not be allowed to consume fluids during exercise.
Exercise will be arrested if participants experience signs/symptoms of heat illness, get exhausted, or no longer want to continue.
Following exercise, sweat collection devices will be collected and analyzed for sweat electrolyte concentration and/or sweat rate detection.
Upon completion of exercise, participants will towel dry and have nude body mass measured again.
They will be provided fluids and snacks following exercise while monitored for 15min post-exercise.
Following this, they will be allowed to leave once they have been scheduled for their second trial.
Following their second trial, they will be compensated for their participation.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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 Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72701
- University of Arkansas Exercise Science Research Center
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy exercisers
- No orthopedic injury
- No chronic conditions
- Able to exercise for 60min in the heat
Exclusion Criteria:
- Chronic conditions
- Not 18y or over 39y
- Taking medications that alter fluid balance or thermoregulation
- Current orthopedic injury
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise in the heat
|
Participants wore the hDrop sensor during exercise in the heat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity of hDrop for sweat rate (Liters/hour)
Time Frame: 60 minutes
|
Data will be compared between lab-based and hDrop sweat rate.
Sweat rate (Liters/hourr) will be quantified during exercise.
At the conclusion of 60 minutes of exercise, lab-based sweat rate and hDrop sweat rate data will be compared to determine validity.
|
60 minutes
|
|
Validity of sweat electrolyte losses from hDrop (millimoles/Liter)
Time Frame: 60 minutes of exercise
|
Lab-based and hDrop sweat-sodium concentration (millimoles/Liter).
The data between methods will be compared to determine accuracy/validity of the hDrop device.
|
60 minutes of exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability of hDrop output [sweat rate (Liters/hour)]
Time Frame: Trial 1 compared to trial 2 (both 60 minutes of exercise)
|
Data for 2 matched trials will be compared to determine repeatability/reliability between trials for sweat rate (Liters/hour).
|
Trial 1 compared to trial 2 (both 60 minutes of exercise)
|
|
Sweat-sodium reliability
Time Frame: Trial 1 compared to trial 2 (60 minutes of exercise)
|
Trial data for sweat-sodium concentration (millimoles/Liter) will be compared between trials for hDrop to determine reliability/repeatability of the device.
|
Trial 1 compared to trial 2 (60 minutes of exercise)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 7, 2025
Primary Completion (Actual)
June 20, 2025
Study Completion (Actual)
February 13, 2026
Study Registration Dates
First Submitted
March 2, 2026
First Submitted That Met QC Criteria
March 18, 2026
First Posted (Actual)
March 24, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2502587094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be shared according to reasonable requests made to the corresponding contact here, or within peer-reviewed publications.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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