Clinical trial NCT07005895: Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydration
Keywords: transdermal optical imaging
TOI
app
user engagement
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Activity tracker-wearing adult

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.

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.

Primary outcomes:
measure: User engagement and feasibility: Subjective and self-reported markers of hydration status
timeFrame: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions
measure: User engagement and feasibility: Markers of hydration using transdermal optical imaging (TOI)
timeFrame: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions
Secondary outcomes:
measure: Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection
timeFrame: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions
Other outcomes:
measure: Self-reported measure of hydration status: Body mass
timeFrame: 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
measure: Self-reported measure of hydration status: Urine color
timeFrame: 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
measure: Self-reported measure of hydration status: Perceived thirst
timeFrame: 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
measure: Self-reported measure of hydration status: Feeling hydrated
timeFrame: 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
Locations:
city: Chicago
country: United States
facility: Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
state: Illinois
Study officials:
affiliation: Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
name: Shellen Goltz, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: