HydrationNCT07005895
Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
An observational study of Hydration, run by PepsiCo Global R&D at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Hydration assessment via mobile app
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Activity tracker-wearing adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
Chicago, Illinois, 60607
Shellen Goltz: Do not contact to participate, PhD, RD
About this study
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
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.
- Conditions
- Hydration
- Being tested
- Hydration assessment via mobile app
- Keywords
- transdermal optical imaging, TOI, app, user engagement
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration assessment via mobile appOther
Open the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult user of a wearable activity tracker | Male or female 18-65 who wears their own activity tracker daily Receives: Other: Hydration assessment via mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start6 May 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shellen Goltz, PhD, RD, Principal investigator, Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005895
- Sponsor's protocol ID
- PEP-2503
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07005895
- Acronym / sponsor ID
- PEP-2503
- Conditions
- Hydration
- Keywords
- transdermal optical imaging, TOI, app, user engagement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult user of a wearable activity tracker | – | Other: Hydration assessment via mobile appMale or female 18-65 who wears their own activity tracker daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Activity tracker-wearing adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration assessment via mobile appOpen the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment' | Other | Healthy adult user of a wearable activity tracker |
Primary outcome
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
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)
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Hydration
Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shellen Goltz, PhD, RD principal investigator
Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydration, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shellen Goltz, PhD, RD (312-821-3317, Shellen.Goltz@pepsico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.