Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

EXERCISE with fluid replacement

GENPOP Passive dehydration (75% reduction in fluid intake

GENPOP Ad lib fluid intake

Clinical Study ID

NCT06044610

PEP-2306 3a

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study Summary

The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status.

This is an exploratory pilot proof of concept study with each subject serving as their own control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subject is male or female
If female, subject is not pregnant
For GENPOP study subject is 18-65 years of age, inclusive
For EXERCISE study subject is 18-50 years of age, inclusive
Subject is moderately-trained (engages in moderate-intensity, intermittent, orsteady-state exercise at least 3 days per week for at least 1 hour at a time (EXERCISEsession participants only)
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 asindicated on the general health questionnaire (GHQ)
Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
Subject is willing to fast overnight (~8-12 hours)
For GENPOP, subject is willing to refrain from vigorous exercise for 48 hours
For EXERCISE, subject is willing to refrain from vigorous exercise for 24 hours priorto study visits
Subject is willing to eat the exact same food the day prior to each visit to thelaboratory
Subject is willing to avoid wearing makeup to the study session
Subject is willing to shave facial hair if predetermined during the informed consentsession it will interfere with TOI measurement
Able to speak, write, and read English
Provision of written consent to participate

Exclusion

Exclusion Criteria:

Subject has participated 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 wouldinterfere with his/her ability to provide informed consent, comply with the studyprotocol, which might confound the interpretation of the study results, or put theperson at undue risk
Subject is allergic to alcohol or facial cleansing wipes
Subject has a history of anaphylaxis or severe allergic reactions
Subjects has a health condition or is taking medication that can be worsened by fluidrestriction
Subject has asthma or other condition which breathing can become labored duringexercise (EXERCISE session participants only)
Male subjects with a VO2max < 42 ml/kg/min and females with a VO2max < 38 ml/kg/min (EXERCISE session participants only)
Subject is employed by, or has a parent, guardian, or other immediate family memberemployed by a company that manufactures any products that compete with any Gatoradeproduct. If subject is unsure if a company would be considered a competitor toGatorade, they will be asked to please let the study investigator know the name of theother company and the nature of their relationship to that company before they signthe informed consent.

Study Design