Wrist wearable using light signals to check hydration
Wearable Photoplethysmography for Non-invasive Hydration Assessment
This trial will test whether a wrist-worn optical sensor can detect changes in hydration during exercise in healthy adults aged 18–45.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Locations | 2 sites (Frisco, Texas and 1 other locations) |
| Trial ID | NCT07520344 on ClinicalTrials.gov |
What this trial studies
The study uses wearable photoplethysmography (PPG) to record superficial blood flow patterns while participants perform exercise and controlled fluid restriction. Participants will wear a wrist device and undergo standardized hydration changes induced by fluid restriction and exercise, with comparisons to conventional hydration measures. Data from the optical sensor will be analyzed for signals that correlate with body water loss. The goal is to develop a noninvasive wearable metric that tracks hydration status.
Who should consider this trial
Good fit: Healthy adults aged 18–45 who can fast overnight, refrain from vigorous exercise before visits, agree to fluid restriction and wear a wrist device, and are not pregnant or taking interfering medications.
Not a fit: People outside the 18–45 age range, those with medical conditions or medications that affect circulation or hydration, pregnant or breastfeeding individuals, or anyone unwilling to undergo fluid restriction and exercise are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could enable simple, noninvasive hydration monitoring from a wrist wearable to help people avoid dehydration during exercise.
How similar studies have performed: Several groups have attempted to derive hydration metrics from wearable optical signals but a reliable, validated wearable-based hydration metric has not yet been established, so the approach remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study subject is 18-45 years of age, inclusive * Subject is male or female * If female, subject is not pregnant, planning to get pregnant, or currently breast feeding * Subject is willing to avoid alcohol consumption 24 hours prior to visit(s) * Able to speak, write, and read English * Provision of written consent to participate * Subject is not taking medication that may interfere with the study, as indicated on the general health questionnaire (GHQ) * Subject has no health conditions that would prevent completion of the trial, as indicated on the GHQ * Subject is willing to fast overnight (no food or beverage, only water, \~8- 10 hours) * Subject is willing to refrain from vigorous exercise for 24 hours * Subject is willing to eat the exact same food the day prior to each visit to the testing site * Subject is willing to undergo fluid restriction to induce dehydration * Subject is willing to wear a wrist worn wearable device for the duration of the study Exclusion Criteria: * Subject has participated or currently enrolled in a clinical trial within the past 30 days * Subject has participated in any PepsiCo trial within the past 3 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, as indicated on the GHQ * 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. * Subject has a health condition or is taking medication that can be worsened by fluid restriction, as indicated on the GHQ
Where this trial is running
Frisco, Texas and 1 other locations
- PepsiCo R&D — Frisco, Texas, United States (Recruiting)
- PepsiCo R&D — Plano, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Anthony Wolfe
- Email: anthony.wolfe@pepsico.com
- Phone: 574-315-5901
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.