Using a smartphone to measure hydration levels in healthy adults and athletes
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development
This study is testing if a smartphone can accurately measure hydration levels in healthy adults and athletes throughout the day and before and after workouts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Locations | 4 sites (Bradenton, Florida and 3 other locations) |
| Trial ID | NCT06212518 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize smartphone-based Transdermal Optical Imaging (TOI) to assess hydration status in both healthy adults and athletes. Participants will undergo hydration assessments at various times over a 24-hour period, as well as before and after training sessions for athletes. The study will compare TOI data with standard hydration measures, with each participant serving as their own control. The goal is to develop a reliable model for detecting hydration changes non-invasively.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-65 who do not smoke and are not taking medications that could interfere with the study.
Not a fit: Patients with health conditions that prevent them from completing the trial or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a convenient and non-invasive method for individuals to monitor their hydration status.
How similar studies have performed: While the use of TOI for hydration assessment is innovative, similar non-invasive hydration monitoring techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Both Study Arms (GENPOP and ATHLETE) * Subject is male or female * If female, subject is not pregnant * Subject is willing to avoid alcohol consumption 24 hours prior to visit(s) * Subject is willing to avoid wearing makeup to the study session or willing to remove it with facial wipes before the face scans * Subject is willing to shave facial hair if predetermined during the informed consent session it will interfere with TOI measurement * Able to speak, write, and read English * Provision of written consent to participate GENPOP Study * Study subject is 18-65 years of age, inclusive * Subject does not smoke (or has quit for at least 6 months) * Subject is not taking medication that may interfere with the study * Subject has no health conditions that would prevent completion of the trial as indicated on the general health questionnaire (GHQ) * Subject is willing to fast overnight (\~8-12 hours) * Subject is willing to refrain from vigorous exercise for 48 hours * Subject is willing to eat the exact same food the day prior to each visit to the testing site ATHLETE Study * Study subject is 14-45 years of age, inclusive * Subject is participating in team sport training/competition * Subject is participating in a coach-led practice Exclusion Criteria: Both Study Arms (GENPOP and ATHLETE) * Subject has participated or currently enrolled in a clinical trial within the past 30 days * Subject has participated in any PepsiCo trial within past 6 months * Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk * Subject is allergic to alcohol or facial cleansing wipes * 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. GENPOP Study • Subject has a health condition or is taking medication that can be worsened by fluid restriction (participants who opt-in to fluid restriction study arm only)
Where this trial is running
Bradenton, Florida and 3 other locations
- Pepsico R&D Life Sciences — Bradenton, Florida, United States (Recruiting)
- PepsiCo R&D Gatorade Sports Science Institute — Chicago, Illinois, United States (Recruiting)
- PepsiCo R&D, Gatorade Sports Science Institute — Valhalla, New York, United States (Recruiting)
- PepsiCo R&D, Gatorade Sports Science Institute — Plano, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Matt Hinkley, PhD — Pepsico, Inc. Sports Science
- Study coordinator: Matthew Hinkley, PhD
- Email: Matt.Hinkley@pepsico.com
- Phone: 914-742-4975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.