Validity of Smart Cap and Smart Sweat Patch

PepsiCo

Status

Completed

Conditions

Fluid Intake in Athletes

Sweating Rate in Athletes

Sweat Chloride Concentration in Athletes

Treatments

Other: Bottle Scale, all subjects - running, fitness, cycling

Device: Sweat Patch, all subjects- running, fitness, cycling

Device: Smart Cap, running and fitness exercisers only

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04920266

PEP-2104

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

173 participants in 4 patient groups, including a placebo group

Smart sweat patch for sweat rate and sweat chloride concentration

Experimental group

Description:

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.

Treatment:

Device: Sweat Patch, all subjects- running, fitness, cycling

Reference sweat patch for sweat rate and sweat electrolytes

Placebo Comparator group

Description:

Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography

Treatment:

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

Smart Cap bottle fluid measurement

Experimental group

Description:

Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection