Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes

Launched by PEPSICO GLOBAL R&D · Jan 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check how hydrated people are using a smartphone-based technology called Transdermal Optical Imaging (TOI). The researchers want to see if this method can accurately measure hydration in two groups: healthy adults and athletes. They will collect information about hydration levels at different times throughout the day for the general population and before and after training sessions for athletes. This study aims to create a better understanding of hydration without needing any invasive procedures.

To participate, you need to be between 18 to 65 years old for the general population group or 14 to 45 years old for the athlete group, and not be pregnant if you're female. Participants should also be healthy, not smoke, and be willing to follow specific guidelines, like avoiding alcohol and vigorous exercise before the study. If you join, you can expect to undergo hydration assessments while following a simple protocol. It's important to note that if you’re involved in any other clinical trials or have certain medical conditions, you may not be eligible. This study could help improve hydration monitoring for everyone, especially athletes!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Both Study Arms (GENPOP and ATHLETE)
• • Subject has participated or currently enrolled 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 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
• • Subject is allergic to alcohol or facial cleansing wipes
• • 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.
• • GENPOP Study
• • • Subject has a health condition or is taking medication that can be worsened by fluid restriction (participants who opt-in to fluid restriction study arm only)