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NCT Number: NCT07005895

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

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences

Chicago, Illinois, 60607, United States

Location status: Recruiting

Location contact

Shellen Goltz: Do not contact to participate, PhD, RD

CONTACT

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydration assessment via mobile app

Other

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

Primary outcomes

  1. User engagement and feasibility: Subjective and self-reported markers of hydration status

    Time frame: 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

  2. User engagement and feasibility: Markers of hydration using transdermal optical imaging (TOI)

    Time frame: 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 outcomes

  1. Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection

    Time frame: 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

Other outcomes

  1. Self-reported measure of hydration status: Body mass

    Time frame: 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

    Home scale body mass, against the TOI hydration model prediction

  2. Self-reported measure of hydration status: Urine color

    Time frame: 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

    Urine 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

  3. Self-reported measure of hydration status: Perceived thirst

    Time frame: 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

    Thirst rating in the app using a 7-point categorical scale, against the TOI hydration model prediction

  4. Self-reported measure of hydration status: Feeling hydrated

    Time frame: 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 the app, select Yes or No as to whether feeling sufficiently hydrated or not, against the TOI hydration model prediction

Study contacts

Contact information is provided by the study sponsor or research team.

Shellen Goltz, PhD, RD

CONTACT

[email protected]

312-821-3317

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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