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
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hydration status, including: 1) at various timepoints throughout a 24-hour period in healthy adults from the general population (GENPOP), and 2) before and after a team coach-led training session in athletes competing in a sport (ATHLETE). TOI data will be collected alongside standard reference measures of hydration status. In this study each subject will serve as their own control.
⁃ 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