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

Recruiting

• Conditions: Hydration

• Registration Number: NCT07005895
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-06
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status
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	Understand user engagement and feasibility of remotely collecting markers of hydration using transdermal optical imaging (TOI)

Secondary Outcome Measures

Name	Time	Method
Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection	At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions	Within subject variation in the tertiary outcomes listed in Other Pre-specified Outcomes 4-7

Trial Locations

Locations (1)

Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences; 🇺🇸 Chicago, Illinois, United States