CompletedNot Applicable

Validity of Smart Cap and Smart Sweat Patch

United States173 participantsStarted 2021-06-08

Plain-language 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.

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fluid intake

Timeframe: Change from baseline to up to 1 hour of exercise

Regional sweating rate

Timeframe: Change from baseline to up to 2 hours of exercise

Regional sweat chloride concentration

Timeframe: Change from baseline to up to 2 hours of exercise

Trial details

NCT IDNCT04920266

SponsorPepsiCo Global R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-25

View on ClinicalTrials.gov More Fluid Intake in Athletes trials