NCT07005895

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 12, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

transdermal optical imagingTOIappuser engagement

Outcome Measures

Primary Outcomes (2)

  • 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

    At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions

  • 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)

    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

    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 (4)

  • Self-reported measure of hydration status: Body mass

    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

  • Self-reported measure of hydration status: Urine color

    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

  • Self-reported measure of hydration status: Perceived thirst

    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

  • +1 more other outcomes

Study Arms (1)

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

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

Healthy adult user of a wearable activity tracker

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Activity tracker-wearing adult

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chicago, Illinois, 60607, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shellen Goltz, PhD, RD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shellen Goltz, PhD, RD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 5, 2025

Study Start

May 6, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations