Wearable Photoplethysmography for Non-invasive Hydration Assessment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPepsiCo Global R&D

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Exercise

    Other intervention

    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))

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Euhydrated GroupOther 1 intervention
Group B: Dehydrated GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wearable Sensr Data

photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.

Time frame
Continuous data collection over 24 hours from start of exercise trial through completion of Day 2 measurements.
2

Body Mass Change

Time frame
Change in body mass during 60 min exercise bout and over 24 hours from baseline

Secondary outcomes

1

Urine Specific Gravity

au

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
2

Urine Volume

g

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
3

Urine Color

Scale of 1 (most hydrated) to 7 (most dehydrated)

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
4

Sweat Rate

\[Body mass loss (kg) + fluid intake (mL)\]/Duration of exercise (hr)

Time frame
Throughout entire duration of 60 min exercise bout

Other outcomes

Sponsors and contacts

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