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

NCT04920266•PepsiCo Global R&D

View on ClinicalTrials.gov

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

Age

16 - 65 years

Sex

ALL

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.

Locations (3)

Gatorade Sports Science Institute (GSSI), 617 West Main Street

Barrington, Illinois, United States

Grant Park, 337 E Randolph St

Chicago, Illinois, United States

Cuba Marsh Forest Preserve, 24205 Cuba Rd

Deer Park, Illinois, United States

Key Dates

Start Date

June 8, 2021

Primary Completion Date

August 25, 2022

Completion Date

August 25, 2022

Last Updated

November 14, 2022

Enrollment

173

ACTUAL participants

Conditions

Fluid Intake in AthletesSweating Rate in AthletesSweat Chloride Concentration in Athletes

Interventions

Smart Cap, running and fitness exercisers only

DEVICE

Sweat Patch, all subjects- running, fitness, cycling

DEVICE

Reference sweat patch, all subjects - running, fitness, cycling

DEVICE

Bottle Scale, all subjects - running, fitness, cycling

OTHER