Validity of Smart Cap and Smart Sweat Patch
- Conditions
- Fluid Intake in AthletesSweat Chloride Concentration in AthletesSweating Rate in Athletes
- Interventions
- Device: Sweat Patch, all subjects- running, fitness, cyclingDevice: Reference sweat patch, all subjects - running, fitness, cyclingOther: Bottle Scale, all subjects - running, fitness, cyclingDevice: Smart Cap, running and fitness exercisers only
- Registration Number
- NCT04920266
- Lead Sponsor
- PepsiCo Global R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Smart sweat patch for sweat rate and sweat chloride concentration Sweat Patch, all subjects- running, fitness, cycling 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. Reference sweat patch for sweat rate and sweat electrolytes Reference sweat patch, all subjects - running, fitness, cycling Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography Reference method bottle fluid measurement Bottle Scale, all subjects - running, fitness, cycling Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists) Smart Cap bottle fluid measurement Smart Cap, running and fitness exercisers only Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection
- Primary Outcome Measures
Name Time Method Regional sweating rate Change from baseline to up to 2 hours of exercise Sweat Patch versus Reference patch method
Regional sweat chloride concentration Change from baseline to up to 2 hours of exercise Sweat Patch versus Reference patch method
Fluid intake Change from baseline to up to 1 hour of exercise Smart Cap (sensor) versus Reference method (bottle weight)
- Secondary Outcome Measures
Name Time Method Regional sweat sodium and potassium with versus without tattoos Change from baseline to up to 2 hours of exercise Reference sweat patch method
Regional sweating rate with versus without tattoos Change from baseline to up to 2 hours of exercise Reference sweat patch method
Whole body sweat rate Body mass change from baseline to up to 2 hours of exercise Scale weight
Trial Locations
- Locations (3)
Gatorade Sports Science Institute (GSSI), 617 West Main Street
🇺🇸Barrington, Illinois, United States
Cuba Marsh Forest Preserve, 24205 Cuba Rd
🇺🇸Deer Park, Illinois, United States
Grant Park, 337 E Randolph St
🇺🇸Chicago, Illinois, United States