Sweat Patch Validation

NCT04240951 | Completed

• 1 other identifier: PEP-1714
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sweat Analysis

Keywords

sweating rate; sweat electrolytes; sweat patch; wearable; epidermal; sweat electrolyte concentrations

Outcome Measures

Primary Outcomes (1)

• Sweat chloride concentration

  Prototype vs. reference method (regional absorbent patch technique) during exercise

  1.5 hours in sessions 1-6

Secondary Outcomes (7)

• Regional sweating rate

  1.5 hours in sessions 1-6

• Whole body sweating rate

  1.5 hours in sessions 1-6

• Whole body sweat chloride concentration

  1.5 hours in sessions 3-4

• Whole body sweat sodium concentration

  1.5 hours in sessions 3-4

• Self-ratings of perceived sweating vs. measured sweating rate

  Prior to the start of exercise at sessions 1-6

Study Arms (6)

Study Session 1

OTHER

Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory

Other: Sweat patch

Study Session 2 (repeat of Study Session 1)

OTHER

Arm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory

Other: Sweat patch

Study Session 3

OTHER

Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory

Other: Sweat patch

Study Session 4 (repeat of Study Session 3)

OTHER

Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory

Other: Sweat patch

Study Session 5

OTHER

Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field

Other: Sweat patch

Study Session 6 (repeat of Study Session 5)

OTHER

Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field

Other: Sweat patch

Interventions

Sweat patch OTHER

Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 1; Study Session 2 (repeat of Study Session 1); Study Session 3; Study Session 4 (repeat of Study Session 3); Study Session 5; Study Session 6 (repeat of Study Session 5)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (2)

Gatorade Sports Science Institute at IMG Academy

Bradenton, Florida, 34210, United States

Location

Gatorade Sports Science Institute (GSSI)

Barrington, Illinois, 60010, United States

Location

Related Publications (1)

• King MA, Brown SD, Barnes KA, De Chavez PJD, Baker LB. Regional and time course differences in sweat cortisol, glucose, and select cytokine concentrations during exercise. Eur J Appl Physiol. 2023 Aug;123(8):1727-1738. doi: 10.1007/s00421-023-05187-3. Epub 2023 Apr 2.

  PMID: 37005963 DERIVED

Study Officials

• Lindsay B Baker, PhD

  PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Barrington site

  PRINCIPAL INVESTIGATOR

• Khalil Lee, PhD

  PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Bradenton site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: August 21, 2017
• Primary Completion: October 24, 2020
• Study Completion: October 24, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

US (2)