Sweat Patch Validation

Study Overview
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Brief Summary
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To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.

Official Title
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Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise

Conditions
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Sweat Analysis

Intervention / Treatment
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* Other: Sweat patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female Subject is 15-45 years Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time) Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max ≥ 42 ml/kg/min if male or ≥ 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory If participating in Study Session 1, 2, 3, or 4, subject has a normal fasting blood glucose (70-110 mg/dl), as measured during the screening at the GSSI laboratory If participating in Study Session 1, 2, 3, or 4, subject has a normal resting blood pressure (< 140/90 mmHg), as measured during the screening at the GSSI laboratory If participating in Study Session 1, 2, 3, or 4, subject has a normal resting and graded exercise EKG, as measured during the screening at the GSSI laboratory If participating in Study Session 1, 2, 3, or 4, willing to be shaved at patch sites If participating in Study Session 3 or 4, willing to undergo a nude shower by an investigator of the same sex for collection of sweat electrolytes in the whole body wash procedure If participating in Study Session 5 or 6, subject is a trained team-sport athlete currently participating in training/competition at IMG Academy Exclusion Criteria: Subject is pregnant (self-reported) Subject is a smoker Subject has a body weight that is lighter than 80 pounds Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease Subject has a history of problems with the gag reflex Subject has not had previous gastrointestinal surgery Subject has problems with swallowing Subject is planning to have an MRI scan during the time that the CorTemp™ Core Body Temperature Sensor is in the body Subject has slow movement of the gastrointestinal tract Subject has a cardiac pacemaker or other implanted electronic device Subject has asthma or other condition in which breathing can become difficult/labored during exercise (applies to Study Session 1-4 only) Subject is allergic to adhesives Subject is currently taking a medication or oral supplement that could interfere with study results 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 has been enrolled into a PepsiCo-sponsored study within the past six months Subject has been enrolled into a clinical trial at a laboratory or clinic other than PepsiCo within the past 30 days 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: 15 Years
Maximum Age: 45 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: Single Group Assignment
Interventional Model Description: Each subject subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Session 1<br>Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|
| Other: Study Session 2 (repeat of Study Session 1)<br>Arm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|
| Other: Study Session 3<br>Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|
| Other: Study Session 4 (repeat of Study Session 3)<br>Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|
| Other: Study Session 5<br>Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|
| Other: Study Session 6 (repeat of Study Session 5)<br>Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field | Other: Sweat patch<br>* Flexible, epidermal, wearable skin patch to collect and analyze sweat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sweat chloride concentration | Prototype vs. reference method (regional absorbent patch technique) during exercise | 1.5 hours in sessions 1-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional sweating rate | Prototype vs. reference method (gravimetry using the regional absorbent patch technique) during exercise | 1.5 hours in sessions 1-6 | 
| Whole body sweating rate | Prototype vs. reference method (changes in nude body mass corrected for fluid intake, urine output, respiratory water loss, and metabolic mass loss) during exercise | 1.5 hours in sessions 1-6 | 
| Whole body sweat chloride concentration | Prototype vs. reference method (whole body washdown technique) during exercise | 1.5 hours in sessions 3-4 | 
| Whole body sweat sodium concentration | Reference method only. Compare whole body sweat chloride concentration vs. whole body sweat sodium concentration during exercise | 1.5 hours in sessions 3-4 | 
| Self-ratings of perceived sweating vs. measured sweating rate | Multiple choice questionnaire vs. sweat patch analysis | Prior to the start of exercise at sessions 1-6 | 
| Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations | Multiple choice questionnaire vs. sweat patch analysis | Prior to the start of exercise at sessions 1-6 | 
| History of exercise-associated muscle cramps | Multiple choice questionnaire | Prior to the start of exercise at sessions 1-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sweating rate, sweat electrolytes, sweat patch, wearable, epidermal, sweat electrolyte concentrations