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Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
NCT07005895 · PepsiCo Global R&D
In plain English
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Official title
Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes: User Engagement and Individual Variability of Transdermal Optical Imaging Features Before and After Acute Fluid Ingestion
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-06
Estimated completion: 2025-12-30
Last updated: 2025-06-05
Interventions
Other: Hydration assessment via mobile app
Primary outcomes
- • User engagement and feasibility: Subjective and self-reported markers of hydration status (At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions)
- • User engagement and feasibility: Markers of hydration using transdermal optical imaging (TOI) (At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions)
Sponsor
PepsiCo Global R&D · industry
Contacts & investigators
ContactShellen Goltz, PhD, RD · contact · Shellen.Goltz@pepsico.com · 312-821-3317
InvestigatorShellen Goltz, PhD, RD · principal_investigator, Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
All locations (1)
Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life SciencesRecruiting
Chicago, Illinois, United States