Sweat Patch Validation

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    PepsiCo Global R&D
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Updated on 16 February 2024
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Summary

To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.

Details
Condition Sweat Analysis
Age 15years - 45years
Treatment Sweat patch
Clinical Study IdentifierNCT04240951
SponsorPepsiCo Global R&D
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject is male or female
Subject is 15-45 years
Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time)
Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history
If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max 42 ml/kg/min if male or 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory
If participating in Study Session 1, 2, 3, or 4, subject has a normal fasting blood glucose (70-110 mg/dl), as measured during the screening at the GSSI laboratory
If participating in Study Session 1, 2, 3, or 4, subject has a normal resting blood pressure (< 140/90 mmHg), as measured during the screening at the GSSI laboratory
If participating in Study Session 1, 2, 3, or 4, subject has a normal resting and graded exercise EKG, as measured during the screening at the GSSI laboratory
If participating in Study Session 1, 2, 3, or 4, willing to be shaved at patch sites
If participating in Study Session 3 or 4, willing to undergo a nude shower by an investigator of the same sex for collection of sweat electrolytes in the whole body wash procedure
If participating in Study Session 5 or 6, subject is a trained team-sport athlete currently participating in training/competition at IMG Academy

Exclusion Criteria

Subject is pregnant (self-reported)
Subject is a smoker
Subject has a body weight that is lighter than 80 pounds
Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease
Subject has a history of problems with the gag reflex
Subject has not had previous gastrointestinal surgery
Subject has problems with swallowing
Subject is planning to have an MRI scan during the time that the CorTemp Core Body Temperature Sensor is in the body
Subject has slow movement of the gastrointestinal tract
Subject has a cardiac pacemaker or other implanted electronic device
Subject has asthma or other condition in which breathing can become difficult/labored during exercise (applies to Study Session 1-4 only)
Subject is allergic to adhesives
Subject is currently taking a medication or oral supplement that could interfere with study results
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 has been enrolled into a PepsiCo-sponsored study within the past six months
Subject has been enrolled into a clinical trial at a laboratory or clinic other than PepsiCo within the past 30 days
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
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