MedPath

Validity of Smart Cap and Smart Sweat Patch

Not Applicable
Completed
Conditions
Fluid Intake in Athletes
Sweat Chloride Concentration in Athletes
Sweating Rate in Athletes
Interventions
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
Device: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Smart sweat patch for sweat rate and sweat chloride concentrationSweat Patch, all subjects- running, fitness, cyclingEpidermal 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 electrolytesReference sweat patch, all subjects - running, fitness, cyclingRegional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography
Reference method bottle fluid measurementBottle Scale, all subjects - running, fitness, cyclingScale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists)
Smart Cap bottle fluid measurementSmart Cap, running and fitness exercisers onlyFluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection
Primary Outcome Measures
NameTimeMethod
Regional sweating rateChange from baseline to up to 2 hours of exercise

Sweat Patch versus Reference patch method

Regional sweat chloride concentrationChange from baseline to up to 2 hours of exercise

Sweat Patch versus Reference patch method

Fluid intakeChange from baseline to up to 1 hour of exercise

Smart Cap (sensor) versus Reference method (bottle weight)

Secondary Outcome Measures
NameTimeMethod
Regional sweat sodium and potassium with versus without tattoosChange from baseline to up to 2 hours of exercise

Reference sweat patch method

Regional sweating rate with versus without tattoosChange from baseline to up to 2 hours of exercise

Reference sweat patch method

Whole body sweat rateBody 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

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