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Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes

PepsiCo logo

PepsiCo

Status

Enrolling

Conditions

Hydration

Treatments

Other: Hydration assessment via mobile app

Study type

Observational

Funder types

Industry

Identifiers

NCT07005895
PEP-2503

Details and patient eligibility

About

This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.

Full description

The primary objective is to understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status as well as markers of hydration using transdermal optical imaging (TOI) within the Gatorade Sports Science Institute (GSSI) branded mobile application (adherence and dropout rates, and differences between demographics). The secondary objective is to understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection.

Tertiary objectives are to compare self-reported measures of hydration status against the TOI hydration model prediction before and after acute fluid ingestion during remote data collection.

An outside service was contracted for recruiting. Please do not contact the investigator to express interest.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-65 years of age, inclusive
  • Male or female. If female, subject is not pregnant, planning to get pregnant, or currently breast feeding
  • Able to speak, write, and read English
  • Provision of written consent to participate
  • Owns and wears an activity tracker daily, including during sleep, except when submerged underwater (i.e., swimming, bathing) and is willing to connect their device to the app, per GSSI Labs App requirements (Oura, WHOOP, Apple Watch, Garmin, Polar, Withings, or Fitbit).
  • Owns a bathroom scale
  • Able to drink 600mL (600 mL = 20 oz = 2 ½ cups) of water as directed.
  • Willing to avoid alcohol consumption 24 hours prior to study session(s)

Exclusion criteria

  • Subject is currently enrolled in a clinical trial or has participated in a clinical trial 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 product. 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.

Trial design

200 participants in 1 patient group

Healthy adult user of a wearable activity tracker
Description:
Male or female 18-65 who wears their own activity tracker daily
Treatment:
Other: Hydration assessment via mobile app

Trial contacts and locations

1

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Central trial contact

Shellen Goltz, PhD, RD

Data sourced from clinicaltrials.gov

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