Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise

PepsiCo Global R&D2 sites in 1 country552 target enrollmentAugust 21, 2017

ConditionsSweat Analysis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sweat Analysis
Sponsor: PepsiCo Global R&D
Enrollment: 552
Locations: 2
Primary Endpoint: Sweat chloride concentration
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 21, 2017

End Date

October 24, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

PepsiCo Global R&D

Responsible Party

Sponsor

Eligibility 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

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

Outcomes

Primary Outcomes

Sweat chloride concentration

Time Frame: 1.5 hours in sessions 1-6

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

Secondary Outcomes

Regional sweating rate(1.5 hours in sessions 1-6)
Whole body sweat chloride concentration(1.5 hours in sessions 3-4)
Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations(Prior to the start of exercise at sessions 1-6)
Whole body sweating rate(1.5 hours in sessions 1-6)
Self-ratings of perceived sweating vs. measured sweating rate(Prior to the start of exercise at sessions 1-6)
History of exercise-associated muscle cramps(Prior to the start of exercise at sessions 1-6)
Whole body sweat sodium concentration(1.5 hours in sessions 3-4)