NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players

To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes

Study Overview

• Status: Completed
• Conditions: Sweat Analysis
• Intervention / Treatment: Other: Gx sweat patch; Other: Reference sweat patch

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 18-40 years of age
• Subject is participating in training/competition with the NBA G-league
• Subject is participating in a coach led practice

Exclusion Criteria:

• Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Validation. Gx sweat collection patch; Left ventral forearm placement using Epicore Biosystems Gx patch	Other: Gx sweat patch; Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay
OTHER: Validation. Reference sweat collection patch; Right ventral forearm placement using a well-established methodology as published in peer-reviewed journals	Other: Reference sweat patch; Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional sweat chloride concentration	Gx patch vs. reference patch during exercise. Gx patch analyzed by colorimetry via smartphone app. Reference patch analyzed with ion chromatography	Average across a single practice session on 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional sweating rate	Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry	Average across the same single practice session on the same 1 day as the primary outcome
Whole body sweating rate	Change in body mass from pre- to post-exercise, corrected for fluid/food intake and urine loss. Body mass measured to the nearest 0.01 kg using a digital platform scale	Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Lindsay B Baker, PhD, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2020
• Primary Completion (ACTUAL): November 4, 2021
• Study Completion (ACTUAL): November 4, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: wearable; epidermal; sweating rate; sweat electrolytes; sweat electrolyte concentration; sweat patch; Gx patch
• Other Study ID Numbers: PEP-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No