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OpenTrials
Completed

NCT Number: NCT04920266

Validity of Smart Cap and Smart Sweat Patch

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.

Completed

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gatorade Sports Science Institute (GSSI), 617 West Main Street, Barrington, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smart Cap, running and fitness exercisers only

Device

Bottle cap

Sweat Patch, all subjects- running, fitness, cycling

Device

Regional contralateral forearm patch

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

Device

Regional contralateral forearm patch

Bottle Scale, all subjects - running, fitness, cycling

Other

Bottle weight

Primary outcomes

  1. Fluid intake

    Time frame: Change from baseline to up to 1 hour of exercise

    Smart Cap (sensor) versus Reference method (bottle weight)

  2. Regional sweating rate

    Time frame: Change from baseline to up to 2 hours of exercise

    Sweat Patch versus Reference patch method

  3. Regional sweat chloride concentration

    Time frame: Change from baseline to up to 2 hours of exercise

    Sweat Patch versus Reference patch method

Secondary outcomes

  1. Regional sweating rate with versus without tattoos

    Time frame: Change from baseline to up to 2 hours of exercise

    Reference sweat patch method

  2. Regional sweat sodium and potassium with versus without tattoos

    Time frame: Change from baseline to up to 2 hours of exercise

    Reference sweat patch method

  3. Whole body sweat rate

    Time frame: Body mass change from baseline to up to 2 hours of exercise

    Scale weight

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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