Clinical trial NCT06212518: Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dehydration
Keywords: hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.


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)

Primary outcomes:
measure: Transdermal Optical Imaging (TOI) signals
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
measure: Standard measurement of hydration status: Body mass change
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
measure: Standard measurements of hydration status: Urine specific gravity
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
measure: Standard measurements of hydration status: Urine color
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
measure: Standard measurements of hydration status: Thirst
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Secondary outcomes:
measure: Subject demographics - Age
timeFrame: At screening
measure: Subject demographics - Sex
timeFrame: At screening
measure: Subject demographics - Ethnicity
timeFrame: At screening
measure: Subject demographics - Race
timeFrame: At screening
measure: Fitzpatrick classification of skin color
timeFrame: At screening
measure: Mood scale
timeFrame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
measure: Dietary and fluid intake
timeFrame: For GENPOP from 24 hours prior to Day 1 visit (~8 a.m.) through end of testing period (Day 2 ~8 a.m.). For ATHLETES from 24 hours to prior to start of single ~45 minute exercise session (if fluid restricted) or to end of exercise (if ad lib fluid intake)
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Pepsico R&D Life Sciences
state: Florida
city: Chicago
country: United States
facility: PepsiCo R&D Gatorade Sports Science Institute
state: Illinois
city: Valhalla
country: United States
facility: PepsiCo R&D, Gatorade Sports Science Institute
state: New York
city: Plano
country: United States
facility: PepsiCo R&D, Gatorade Sports Science Institute
state: Texas
Study officials:
affiliation: PepsiCo, Inc. Sports Science
name: Lindsay Baker, PhD
role: STUDY_DIRECTOR
affiliation: Pepsico, Inc. Sports Science
name: Matt Hinkley, PhD
role: PRINCIPAL_INVESTIGATOR
References: