Validity of Smart Cap and Smart Sweat Patch

Study Overview
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Brief Summary
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The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.

Official Title
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Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise

Conditions
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Fluid Intake in Athletes, Sweating Rate in Athletes, Sweat Chloride Concentration in Athletes

Intervention / Treatment
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* Device: Smart Cap, running and fitness exercisers only
* Device: Sweat Patch, all subjects- running, fitness, cycling
* Device: Reference sweat patch, all subjects - running, fitness, cycling
* Other: Bottle Scale, all subjects - running, fitness, cycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female Subject is 16-65 years of age Subject is moderately-trained (participates in regular outdoor fitness ( 1 h), cycling (1-2 h), or running (0.5-1 h) sessions ≥2x per week) Subject is participating in an instructor-led fitness session, typical training run, or group bicycle ride Exclusion Criteria: Subject is pregnant Subject is a smoker Subject is taking a medication or oral supplement that could interfere with study results Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages) Subject has ≥ 2 cardiovascular risk factors as assessed on the General Health History Questionnaire Subject has participated in a clinical trial within past 30 days Subject has participated in any PepsiCo trial within past 6 months Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk Subject is employed by, or has a parent, guardian or other immediate family member employed by, a company that manufactures any products that compete with any Gatorade products. If subject is unsure if a company would be considered a competitor to Gatorade they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will serve as his or her own control. We will compare the Test and Reference methods during moderate intensity self-paced training runs, coach-led fitness sessions, and/or group outdoor cycling rides.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart sweat patch for sweat rate and sweat chloride concentration<br>Epidermal microfluidic patch that is a flexible 27 cm2 platform with an adhesive backing that collects sweat through a skin-facing inlet port. Custom software uses the smartphone camera to capture and analyze the microfluidic patch. | Device: Sweat Patch, all subjects- running, fitness, cycling<br>* Regional contralateral forearm patch<br>|
| Placebo Comparator: Reference sweat patch for sweat rate and sweat electrolytes<br>Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography | Device: Reference sweat patch, all subjects - running, fitness, cycling<br>* Regional contralateral forearm patch<br>|
| Experimental: Smart Cap bottle fluid measurement<br>Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection | Device: Smart Cap, running and fitness exercisers only<br>* Bottle cap<br>|
| Other: Reference method bottle fluid measurement<br>Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists) | Other: Bottle Scale, all subjects - running, fitness, cycling<br>* Bottle weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid intake | Smart Cap (sensor) versus Reference method (bottle weight) | Change from baseline to up to 1 hour of exercise | 
| Regional sweating rate | Sweat Patch versus Reference patch method | Change from baseline to up to 2 hours of exercise | 
| Regional sweat chloride concentration | Sweat Patch versus Reference patch method | Change from baseline to up to 2 hours of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional sweating rate with versus without tattoos | Reference sweat patch method | Change from baseline to up to 2 hours of exercise | 
| Regional sweat sodium and potassium with versus without tattoos | Reference sweat patch method | Change from baseline to up to 2 hours of exercise | 
| Whole body sweat rate | Scale weight | Body mass change from baseline to up to 2 hours of exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sweat, hydration, wearable, exercise