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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

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ClinicalTrials.gov Identifier: NCT04679532
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Sweat Analysis Other: Gx sweat patch Other: Reference sweat patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Each subject serves as their own control. Both devices are worn during the same exercise session.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
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

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




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


Secondary Outcome Measures :
  1. Regional sweating rate [ Time Frame: Average across the same single practice session on the same 1 day as the primary outcome ]
    Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry

  2. Whole body sweating rate [ Time Frame: Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   No females in NBA G-League
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679532


Contacts
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Contact: Lindsay B Baker, PhD 847-304-2142 lindsay.baker@pepsico.com

Locations
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United States, California
NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr. Recruiting
Walnut Creek, California, United States, 94598
Contact: Pete Youngman       PYoungman@nba.com   
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Lindsay B Baker, PhD PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT04679532    
Other Study ID Numbers: PEP-2001
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PepsiCo Global R&D:
sweating rate
sweat electrolytes
sweat electrolyte concentration
sweat patch
wearable
epidermal
Gx patch