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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04920266
Enrollment
173
Registered
2021-06-09
Start date
2021-06-08
Completion date
2022-08-25
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Intake in Athletes, Sweat Chloride Concentration in Athletes, Sweating Rate in Athletes

Keywords

sweat, hydration, wearable, exercise

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.

Interventions

OTHERBottle Scale, all subjects - running, fitness, cycling

Bottle weight

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

Regional contralateral forearm patch

DEVICESmart Cap, running and fitness exercisers only

Bottle cap

DEVICESweat Patch, all subjects- running, fitness, cycling

Regional contralateral forearm patch

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Fluid intakeChange from baseline to up to 1 hour of exerciseSmart Cap (sensor) versus Reference method (bottle weight)
Regional sweating rateChange from baseline to up to 2 hours of exerciseSweat Patch versus Reference patch method
Regional sweat chloride concentrationChange from baseline to up to 2 hours of exerciseSweat Patch versus Reference patch method

Secondary

MeasureTime frameDescription
Regional sweating rate with versus without tattoosChange from baseline to up to 2 hours of exerciseReference sweat patch method
Regional sweat sodium and potassium with versus without tattoosChange from baseline to up to 2 hours of exerciseReference sweat patch method
Whole body sweat rateBody mass change from baseline to up to 2 hours of exerciseScale weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026