Fluid Intake in AthletesNCT04920266

Validity of Smart Cap and Smart Sweat Patch

A study testing Smart Cap, running and fitness exercisers only, Sweat Patch, all subjects- running, fitness, cycling and Reference sweat patch, all subjects - running, fitness, cycling in people with Fluid Intake in Athletes and Sweating Rate in Athletes, run by PepsiCo Global R&D at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Fluid Intake in Athletes, Sweating Rate in Athletes, Sweat Chloride Concentration in Athletes
What is being tested?: Smart Cap, running and fitness exercisers only, Sweat Patch, all subjects- running, fitness, cycling and Reference sweat patch, all subjects - running, fitness, cycling
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 173 participants
Where: 3 sitesUnited States
Study dates: 8 Jun 2021to 25 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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 locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

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.

Conditions: Fluid Intake in Athletes, Sweating Rate in Athletes, Sweat Chloride Concentration in Athletes
Being tested: Smart Cap, running and fitness exercisers only, Sweat Patch, all subjects- running, fitness, cycling, Reference sweat patch, all subjects - running, fitness, cycling, Bottle Scale, all subjects - running, fitness, cycling
Keywords: sweat, hydration, wearable, exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smart Cap, running and fitness exercisers onlyDevice
Bottle cap
Sweat Patch, all subjects- running, fitness, cyclingDevice
Regional contralateral forearm patch
Reference sweat patch, all subjects - running, fitness, cyclingDevice
Regional contralateral forearm patch
Bottle Scale, all subjects - running, fitness, cyclingOther
Bottle weight

Study groups in NCT04920266
Study group	Role	What they receive
Smart sweat patch for sweat rate and sweat chloride concentration	Experimental	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. Receives: Device: Sweat Patch, all subjects- running, fitness, cycling
Reference sweat patch for sweat rate and sweat electrolytes	Placebo comparator	Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography Receives: Device: Reference sweat patch, all subjects - running, fitness, cycling
Smart Cap bottle fluid measurement	Experimental	Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection Receives: Device: Smart Cap, running and fitness exercisers only
Reference method bottle fluid measurement	Other	Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists) Receives: Other: Bottle Scale, all subjects - running, fitness, cycling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202125 Aug 2022

First posted9 Jun 2021
Study start8 Jun 2021
Primary completion25 Aug 2022
Study completion25 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Fluid Intake in AthletesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04920266
Sponsor's protocol ID: PEP-2104
Status last verified: Nov 2022
First submitted: 3 Jun 2021
Last updated: 14 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Merritt JR, Ozga M, De Chavez PJD, Boolani A, Baker LB. No effect of tattoos on local sweat concentrations of select cytokines, cortisol, glucose, blood urea nitrogen, or lactate during exercise. Sci Rep. 2024 May 31;14(1):12570. doi: 10.1038/s41598-024-63057-0.
PubMed 38821996
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.
PubMed 35778519

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04920266
Acronym / sponsor ID: PEP-2104
Conditions: Fluid Intake in Athletes, Sweating Rate in Athletes, Sweat Chloride Concentration in Athletes
Keywords: sweat, hydration, wearable, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Study start: 8 Jun 2021 (actual)
Primary completion: 25 Aug 2022 (actual)
Study completion: 25 Aug 2022 (actual)
First posted: 9 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Smart sweat patch for sweat rate and sweat chloride concentration	Experimental	Device: Sweat Patch, all subjects- running, fitness, cyclingEpidermal 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.
Reference sweat patch for sweat rate and sweat electrolytes	Placebo comparator	Device: Reference sweat patch, all subjects - running, fitness, cyclingRegional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography
Smart Cap bottle fluid measurement	Experimental	Device: Smart Cap, running and fitness exercisers onlyFluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection
Reference method bottle fluid measurement	Other	Other: Bottle Scale, all subjects - running, fitness, cyclingScale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists)

Who may qualify

Ages: 16 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smart Cap, running and fitness exercisers onlyBottle cap	Device	Smart Cap bottle fluid measurement
Sweat Patch, all subjects- running, fitness, cyclingRegional contralateral forearm patch	Device	Smart sweat patch for sweat rate and sweat chloride concentration
Reference sweat patch, all subjects - running, fitness, cyclingRegional contralateral forearm patch	Device	Reference sweat patch for sweat rate and sweat electrolytes
Bottle Scale, all subjects - running, fitness, cyclingBottle weight	Other	Reference method bottle fluid measurement

Primary outcome

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

3 secondary outcomes

Regional sweating rate with versus without tattoos
Time frame: Change from baseline to up to 2 hours of exercise
Regional sweat sodium and potassium with versus without tattoos
Time frame: Change from baseline to up to 2 hours of exercise
Whole body sweat rate
Time frame: Body mass change from baseline to up to 2 hours of exercise

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Derived from this study: PubMed 38821996Merritt JR, Ozga M, De Chavez PJD, Boolani A, Baker LB. No effect of tattoos on local sweat concentrations of select cytokines, cortisol, glucose, blood urea nitrogen, or lactate during exercise. Sci Rep. 2024 May 31;14(1):12570. doi: 10.1038/s41598-024-63057-0.
Derived from this study: PubMed 35778519Keyes 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsay Baker, PhD principal investigator

PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid intake (time frame: Change from baseline to up to 1 hour of exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920266, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.