Validity of Smart Cap and Smart Sweat Patch

Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise

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 Overview

• Status: Completed
• Conditions: Fluid Intake in Athletes; Sweating Rate in Athletes; Sweat Chloride Concentration in Athletes
• Intervention / Treatment: Device: Sweat Patch, all subjects- running, fitness, cycling; Device: Reference sweat patch, all subjects - running, fitness, cycling; Device: Smart Cap, running and fitness exercisers only; Other: Bottle Scale, all subjects - running, fitness, cycling

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Gatorade Sports Science Institute (GSSI), 617 West Main Street
    • Chicago, Illinois, United States, 60601
      • Grant Park, 337 E Randolph St
    • Deer Park, Illinois, United States, 60010
      • Cuba Marsh Forest Preserve, 24205 Cuba Rd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Sweat Patch, all subjects- running, fitness, cycling; Regional contralateral forearm patch
Placebo Comparator: 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	Device: Reference sweat patch, all subjects - running, fitness, cycling; Regional contralateral forearm patch
Experimental: 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	Device: Smart Cap, running and fitness exercisers only; Bottle cap
Other: 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)	Other: Bottle Scale, all subjects - running, fitness, cycling; Bottle weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid intake	Smart Cap (sensor) versus Reference method (bottle weight)	Change from baseline to up to 1 hour of exercise
Regional sweating rate	Sweat Patch versus Reference patch method	Change from baseline to up to 2 hours of exercise
Regional sweat chloride concentration	Sweat Patch versus Reference patch method	Change from baseline to up to 2 hours of exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional sweating rate with versus without tattoos	Reference sweat patch method	Change from baseline to up to 2 hours of exercise
Regional sweat sodium and potassium with versus without tattoos	Reference sweat patch method	Change from baseline to up to 2 hours of exercise
Whole body sweat rate	Scale weight	Body mass change from baseline to up to 2 hours of exercise

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Lindsay Baker, PhD, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: exercise; wearable; sweat; hydration
• Other Study ID Numbers: PEP-2104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No