CClinicalTrials.gg
RecruitingNCT07005895Updated Jun 5, 2025

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

An observational study in Hydration, sponsored by PepsiCo Global R&D. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by PepsiCo Global R&D · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hydration

Keywords

  • transdermal optical imaging
  • TOI
  • app
  • user engagement
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Activity tracker-wearing adult

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

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.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy adult user of a wearable activity tracker

    Male or female 18-65 who wears their own activity tracker daily

    Other: Hydration assessment via mobile app

Interventions

  • OtherHydration assessment via mobile app

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

05

What researchers measure

Primary outcomes

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

    Understand user engagement and feasibility of remotely collecting 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

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

    Understand user engagement and feasibility of remotely collecting 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

Secondary outcomes

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

    Within subject variation in the tertiary outcomes listed in Other Pre-specified Outcomes 4-7

    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

Other outcomes

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

    Home scale body mass, against the TOI hydration model prediction

    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

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

    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

    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

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

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

    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

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

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

    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

06

Study locations

1 of 1 sites recruiting
  • Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
    Chicago, Illinois 60607, United States
    • Shellen Goltz: Do not contact to participate, PhD, RD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07005895
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
May 6, 2025
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jun 5, 2025

Study contacts

Shellen Goltz, PhD, RD
Contact
Shellen.Goltz@pepsico.com
312-821-3317
Shellen Goltz, PhD, RD
principal investigator · Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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