Clinical trial NCT04920266: Validity of Smart Cap and Smart Sweat Patch
Official title: Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Intake in Athletes
Sweating Rate in Athletes
Sweat Chloride Concentration in Athletes
Keywords: sweat
hydration
wearable
exercise
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 173
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fluid intake
timeFrame: Change from baseline to up to 1 hour of exercise
measure: Regional sweating rate
timeFrame: Change from baseline to up to 2 hours of exercise
measure: Regional sweat chloride concentration
timeFrame: Change from baseline to up to 2 hours of exercise
Secondary outcomes:
measure: Regional sweating rate with versus without tattoos
timeFrame: Change from baseline to up to 2 hours of exercise
measure: Regional sweat sodium and potassium with versus without tattoos
timeFrame: Change from baseline to up to 2 hours of exercise
measure: Whole body sweat rate
timeFrame: Body mass change from baseline to up to 2 hours of exercise
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Gatorade Sports Science Institute (GSSI), 617 West Main Street
state: Illinois
city: Chicago
country: United States
facility: Grant Park, 337 E Randolph St
state: Illinois
city: Deer Park
country: United States
facility: Cuba Marsh Forest Preserve, 24205 Cuba Rd
state: Illinois
Study officials:
affiliation: PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)
name: Lindsay Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keyes DM, Brown SD, King MA, Engel MD, Ciciora-Gold M, Chavez PJD, Baker LB. Multiple regression analyses to determine the effect of sweating rate and tattoo characteristics on sweat outcome measures during exercise. Eur J Appl Physiol. 2022 Oct;122(10):2163-2174. doi: 10.1007/s00421-022-04989-1. Epub 2022 Jul 1.