NCT07464743

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 2, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Sweat rateExercise in the heatSweat sodiumValidity

Outcome Measures

Primary Outcomes (2)

  • Sweat rate (L/hr)

    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]

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

    Every 30min during trails with exercise in the heat.

Study Arms (2)

Short trial (30min exercise in the heat)

OTHER

Short trial. We will assess sweat rate and sweat-sodium losses during exercise in the heat.

Other: Exercise in the heat

Long trials (120min exercise in the heat)

OTHER

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

Interventions

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

Long trials (120min exercise in the heat)Short trial (30min exercise in the heat)

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bandiera D, de Bardonneche J, Margout-Jantac D, Dubois L, El Allaoui N, Rubio JSE, Aubin JC, Racinais S, Tessitore A, Pitsiladis Y. Sweat sodium composition and sweat loss estimation through wearable sensors and predictive equations in dry and humid hot conditions. Front Physiol. 2026 Jan 5;16:1717275. doi: 10.3389/fphys.2025.1717275. eCollection 2025.

    PMID: 41561158BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Brendon P. McDermott, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Participants will complete 3 trials each. One trial is 30min in duration, while the last 2 are 120min, involving exercise in the heat. The longer trials will be matched.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 11, 2026

Study Start

February 16, 2026

Primary Completion

May 1, 2026

Study Completion

August 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR