Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
ConditionHydration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPepsiCo Global R&D
About this trial
This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Activity tracker-wearing adult
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Hydration assessment via mobile app
Other interventionOpen the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Healthy adult user of a wearable activity tracker1 intervention
Trial outcomes
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 sessions2
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 sessionsSecondary 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 sessionsOther 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 sessions2
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 sessions3
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 sessions4
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 sessionsSponsors and contacts
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Source ClinicalTrials.gov