Validity of Smart Cap and Smart Sweat Patch

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04920266

Collaborator

(none)

150

Enrollment

Locations

Arms

4.7

Anticipated Duration (Months)

Patients Per Site

10.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fluid Intake in Athletes Sweating Rate in Athletes Sweat Chloride Concentration in Athletes	Device: Smart Cap, running and fitness exercisers only Device: Sweat Patch, all subjects- running, fitness, cycling Device: Reference sweat patch, all subjects - running, fitness, cycling Other: Bottle Scale, all subjects - running, fitness, cycling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jun 2, 2021

Anticipated Primary Completion Date :

Oct 23, 2021

Anticipated Study Completion Date :

Oct 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gatorade Sports Science Institute (GSSI), 617 West Main Street	Barrington	Illinois	United States	60010
2	Grant Park, 337 E Randolph St	Chicago	Illinois	United States	60601
3	Cuba Marsh Forest Preserve, 24205 Cuba Rd	Deer Park	Illinois	United States	60010

Sponsors and Collaborators

PepsiCo Global R&D

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PepsiCo Global R&D

ClinicalTrials.gov Identifier:

NCT04920266

Other Study ID Numbers:

PEP-2104

First Posted:

Jun 9, 2021

Last Update Posted:

Jun 11, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by PepsiCo Global R&D

Study Results

No Results Posted as of Jun 11, 2021