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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07005895
Enrollment
200
Registered
2025-06-05
Start date
2025-05-06
Completion date
2025-12-30
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydration

Keywords

transdermal optical imaging, TOI, app, user engagement

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.

Interventions

OTHERHydration assessment via mobile app

Open the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
User engagement and feasibility: Subjective and self-reported markers of hydration statusAt two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessionsUnderstand 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 sessionsUnderstand user engagement and feasibility of remotely collecting markers of hydration using transdermal optical imaging (TOI)

Secondary

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

Other

MeasureTime frameDescription
Self-reported measure of hydration status: Body massBefore 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 sessionsHome scale body mass, against the TOI hydration model prediction
Self-reported measure of hydration status: Feeling hydratedBefore 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 sessionsWithin the app, select Yes or No as to whether feeling sufficiently hydrated or not, against the TOI hydration model prediction
Self-reported measure of hydration status: Urine colorBefore 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 sessionsUrine color against the TOI hydration model prediction rated from very pale yellow to brown on a 7-color chart, against the TOI hydration model prediction
Self-reported measure of hydration status: Perceived thirstBefore 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 sessionsThirst rating in the app using a 7-point categorical scale, against the TOI hydration model prediction

Countries

United States

Contacts

Primary ContactShellen Goltz, PhD, RD
Shellen.Goltz@pepsico.com312-821-3317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026