Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 173
- Locations
- 3
- Primary Endpoint
- Regional sweating rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Smart sweat patch for sweat rate and sweat chloride concentration
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.
Intervention: Sweat Patch, all subjects- running, fitness, cycling (Device)
Reference sweat patch for sweat rate and sweat electrolytes
Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography
Intervention: Reference sweat patch, all subjects - running, fitness, cycling (Device)
Smart Cap bottle fluid measurement
Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection
Intervention: Smart Cap, running and fitness exercisers only (Device)
Reference method bottle fluid measurement
Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists)
Intervention: Bottle Scale, all subjects - running, fitness, cycling (Other)
Outcomes
Primary Outcomes
Regional sweating rate
Time Frame: Change from baseline to up to 2 hours of exercise
Sweat Patch versus Reference patch method
Regional sweat chloride concentration
Time Frame: Change from baseline to up to 2 hours of exercise
Sweat Patch versus Reference patch method
Fluid intake
Time Frame: Change from baseline to up to 1 hour of exercise
Smart Cap (sensor) versus Reference method (bottle weight)
Secondary Outcomes
- Regional sweat sodium and potassium with versus without tattoos(Change from baseline to up to 2 hours of exercise)
- Regional sweating rate with versus without tattoos(Change from baseline to up to 2 hours of exercise)
- Whole body sweat rate(Body mass change from baseline to up to 2 hours of exercise)