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Sweat Patch Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240951
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Each subject subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Study Session 1
Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 2 (repeat of Study Session 1)
Arm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 3
Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 4 (repeat of Study Session 3)
Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 5
Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat

Study Session 6 (repeat of Study Session 5)
Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field
Other: Sweat patch
Flexible, epidermal, wearable skin patch to collect and analyze sweat




Primary Outcome Measures :
  1. Sweat chloride concentration [ Time Frame: 1.5 hours in sessions 1-6 ]
    Prototype vs. reference method (regional absorbent patch technique) during exercise


Secondary Outcome Measures :
  1. Regional sweating rate [ Time Frame: 1.5 hours in sessions 1-6 ]
    Prototype vs. reference method (gravimetry using the regional absorbent patch technique) during exercise

  2. Whole body sweating rate [ Time Frame: 1.5 hours in sessions 1-6 ]
    Prototype vs. reference method (changes in nude body mass corrected for fluid intake, urine output, respiratory water loss, and metabolic mass loss) during exercise

  3. Whole body sweat chloride concentration [ Time Frame: 1.5 hours in sessions 3-4 ]
    Prototype vs. reference method (whole body washdown technique) during exercise

  4. Whole body sweat sodium concentration [ Time Frame: 1.5 hours in sessions 3-4 ]
    Reference method only. Compare whole body sweat chloride concentration vs. whole body sweat sodium concentration during exercise

  5. Self-ratings of perceived sweating vs. measured sweating rate [ Time Frame: Prior to the start of exercise at sessions 1-6 ]
    Multiple choice questionnaire vs. sweat patch analysis

  6. Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations [ Time Frame: Prior to the start of exercise at sessions 1-6 ]
    Multiple choice questionnaire vs. sweat patch analysis

  7. History of exercise-associated muscle cramps [ Time Frame: Prior to the start of exercise at sessions 1-6 ]
    Multiple choice questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04240951


Contacts
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Contact: Lindsay B Baker, PhD 847.304.2142 lindsay.baker@pepsico.com
Contact: Khalil Lee, PhD 941-201-3811 khalil.lee@pepsico.com

Locations
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United States, Florida
Gatorade Sports Science Institute at IMG Academy Recruiting
Bradenton, Florida, United States, 34210
Contact: Khalil Lee, PhD    941-201-3811    khalil.lee@pepsico.com   
Principal Investigator: Khalil Lee, PhD         
United States, Illinois
Gatorade Sports Science Institute (GSSI) Recruiting
Barrington, Illinois, United States, 60010
Contact: Lindsay B Baker, PhD    847-304-2142    lindsay.baker@pepsico.com   
Principal Investigator: Lindsay B Baker, PhD         
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) PI for Barrington site
Principal Investigator: Khalil Lee, PhD PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Bradenton site
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT04240951    
Other Study ID Numbers: PEP-1714
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 patch
wearable
epidermal
sweat electrolyte concentrations