Hydration StatusNCT07520344
Wearable Photoplethysmography for Non-invasive Hydration Assessment
A study testing Exercise in people with Hydration Status, run by PepsiCo Global R&D at 2 sites in United States.
Trial summary
Hydration status during exercise is often determined by measuring body mass change, fluid intake and urine output. However, obtaining these measurements can be an invasive, time-consuming process. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2026to Oct 2026
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
PepsiCo R&D
Frisco, Texas, 75034
Anthony Wolfe, 574-315-5901, anthony.wolfe@pepsico.com
- Recruiting
PepsiCo R&D
Plano, Texas, 75024
Anthony Wolfe, 574-315-5901, anthony.wolfe@pepsico.com
About this study
Hydration status during exercise is often determined by measuring body mass change, fluid intake and urine output. However, obtaining these measurements can be an invasive, time-consuming process. Hydration status may be detectable by analyzing blood flow patterns of the superficial (just under the skin) blood vessels. Wearable devices are now abundant among the general population, and despite attempts from several groups, a hydration status metric based on noninvasive wearable device metrics has not been developed. With wearables, a light source connected to an optical sensor transmits and reflects light through the body. The light sensor detects absorption of the light based on wavelength measurements of the detected light. Absorption of specific wavelengths of light energy is dependent upon the amount of oxygenated blood in the vessels. When the vessels expand and relax, the amount of blood volume in the observed tissue increases and decreases potentially causing a shift in the photoplethysmography (PPG) wave detected by the wearable. The shift in the shape of the PPG wave may be detected in a way that indicates the relative change in tissue hydration levels. However, to our knowledge, no wrist worn device that utilizes PPG has been successfully able to predict hydration status. Therefore, this study aims to utilize photoplethysmography (PPG) technology in a wearable device to accomplish this approach to hydration monitoring.
- Conditions
- Hydration Status
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Perform stationary cycling exercise in the laboratory for 2 30- minute bouts at a standardized exercise intensity (wattage) that elicits 50-80% heart rate max determined by equation (208-(70% of age))
| Study group | Role | What they receive |
|---|---|---|
| Euhydrated Group | Other | Water provided to account for sweat loss during exercise and to maintain hydration over the 24-hour period Receives: Other: Exercise |
| Dehydrated Group | Experimental | Fluid restriction during exercise and the remaining 24 hours Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearable Sensr Data
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
Measured: Continuous data collection over 24 hours from start of exercise trial through completion of Day 2 measurements.
Body Mass Change
Measured: Change in body mass during 60 min exercise bout and over 24 hours from baseline
Secondary outcomes (12)
Urine Specific Gravity
au
Measured: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Urine Volume
g
Measured: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Urine Color
Scale of 1 (most hydrated) to 7 (most dehydrated)
Measured: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Sweat Rate
[Body mass loss (kg) + fluid intake (mL)]/Duration of exercise (hr)
Measured: Throughout entire duration of 60 min exercise bout
Fluid Intake
mL
Measured: documented by subject on provided log for 24 hours prior to exercise and experimental trials. Exercise bouts- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
Subjective Feelings of Thirst
Categorical Thirst Scale, on a scale of 1 (Not thirsty at all) to 7 (very, very thirsty).
Measured: Day 1 & 2: Following 5 min of rest
Heart Rate
bpm
Measured: At medical screening to determine eligibility. Day 1: Prior to start of exercise bouts during 5 min rest and every 10 min throughout entire duration of each 60 min exercise trial. Day 2: During 5 min rest, prior to body weight measurement.
Blood pressure
systolic/diastolic (mmHg)
Measured: Medical Screening to determine eligibility
Subject Demographics
Age, Sex, Race, and Ethnicity
Measured: At baseline
Dietary Intake
Food intake logs
Measured: Completed for 24 hours prior to baseline and between visits.
Standardized Exercise Intensity
W
Measured: Every 10 min throughout entire duration of each 30 min exercise bout to reach 50-80% of heart rate max.
Rate of Perceived Exertion
Borg Scale, a scale of 6 (No exertion at all) to 20 (maximal exertion)
Measured: Every 10 min throughout entire duration of each 30 min exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start12 May 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration StatusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An interventional randomized, counterbalanced, cross-over design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520344
- Sponsor's protocol ID
- PEP-2516
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Photoplethysmography for Non-invasive Hydration Assessment
- ClinicalTrials.gov ID
- NCT07520344
- Acronym / sponsor ID
- PEP-2516
- Conditions
- Hydration Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
Hydration status during exercise is often determined by measuring body mass change, fluid intake and urine output. However, obtaining these measurements can be an invasive, time-consuming process. Hydration status may be detectable by analyzing blood flow patterns of the superficial (just under the skin) blood vessels. Wearable devices are now abundant among the general population, and despite attempts from several groups, a hydration status metric based on noninvasive wearable device metrics has not been developed. With wearables, a light source connected to an optical sensor transmits and reflects light through the body. The light sensor detects absorption of the light based on wavelength measurements of the detected light. Absorption of specific wavelengths of light energy is dependent upon the amount of oxygenated blood in the vessels. When the vessels expand and relax, the amount of blood volume in the observed tissue increases and decreases potentially causing a shift in the photoplethysmography (PPG) wave detected by the wearable. The shift in the shape of the PPG wave may be detected in a way that indicates the relative change in tissue hydration levels. However, to our knowledge, no wrist worn device that utilizes PPG has been successfully able to predict hydration status. Therefore, this study aims to utilize photoplethysmography (PPG) technology in a wearable device to accomplish this approach to hydration monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An interventional randomized, counterbalanced, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Euhydrated Group | Other | Other: ExerciseWater provided to account for sweat loss during exercise and to maintain hydration over the 24-hour period |
| Dehydrated Group | Experimental | Other: ExerciseFluid restriction during exercise and the remaining 24 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ExercisePerform stationary cycling exercise in the laboratory for 2 30- minute bouts at a standardized exercise intensity (wattage) that elicits 50-80% heart rate max determined by equation (208-(70% of age)) | Other | Dehydrated Group, Euhydrated Group |
Primary outcome
Wearable Sensr Data
Time frame: Continuous data collection over 24 hours from start of exercise trial through completion of Day 2 measurements.
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
Body Mass Change
Time frame: Change in body mass during 60 min exercise bout and over 24 hours from baseline
12 secondary outcomes
Urine Specific Gravity
Time frame: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Urine Volume
Time frame: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Urine Color
Time frame: Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory
Sweat Rate
Time frame: Throughout entire duration of 60 min exercise bout
Fluid Intake
Time frame: documented by subject on provided log for 24 hours prior to exercise and experimental trials. Exercise bouts- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
Subjective Feelings of Thirst
Time frame: Day 1 & 2: Following 5 min of rest
Heart Rate
Time frame: At medical screening to determine eligibility. Day 1: Prior to start of exercise bouts during 5 min rest and every 10 min throughout entire duration of each 60 min exercise trial. Day 2: During 5 min rest, prior to body weight measurement.
Blood pressure
Time frame: Medical Screening to determine eligibility
Subject Demographics
Time frame: At baseline
Dietary Intake
Time frame: Completed for 24 hours prior to baseline and between visits.
Standardized Exercise Intensity
Time frame: Every 10 min throughout entire duration of each 30 min exercise bout to reach 50-80% of heart rate max.
Rate of Perceived Exertion
Time frame: Every 10 min throughout entire duration of each 30 min exercise bout
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
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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
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hydration Status, run by PepsiCo Global R&D at 2 sites 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 13 inclusion and 5 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Anthony Wolfe (574-315-5901, anthony.wolfe@pepsico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable Sensr Data (time frame: Continuous data collection over 24 hours from start of exercise trial through completion of Day 2 measurements.). 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 21 Sep 2026.