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Clinical Trial NCT06212518 for Dehydration is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes

Recruiting
Clinical Trial NCT06212518 is an interventional study for Dehydration that is recruiting. It started on October 2, 2023 with plans to enroll 1,000 participants. Led by PepsiCo Global R&D, it is expected to complete by August 31, 2024. The latest data from ClinicalTrials.gov was last updated on January 19, 2024.
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.

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

Conditions
Dehydration
Other Study IDs
  • PEP-2306 3b
NCT ID Number
NCT06212518
Start Date (Actual)
2023-10-02
Last Update Posted
2024-01-19
Completion Date (Estimated)
2024-08-31
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGENPOP passive dehydration
In the 24 hours between the first and last face scan, reduce fluid intake by approximately 75% (equating to approximately 700 ml (women) and 800 ml (men)). Participants will be provided pre-filled water bottles and asked to only ingest fluid in bottle until second morning face scan.
GENPOP Fluid Restriction
In the 24 hours between the first and last face scan, reduce fluid intake by approximately 75% (equating to approximately 700 ml (women) and 800 ml (men)).
ExperimentalGENPOP ad libitum fluid intake
No fluid restriction
GENPOP Ad Libitum Fluid Intake
Unrestricted fluid intake.
ExperimentalATHLETE with fluid restriction
For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Not permitted to drink during training session.
ATHLETE Restricted Fluid Intake
Not permitted to drink during training session.
ExperimentalATHLETE ad libitum fluid intake
For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Permitted to drink during training session.
ATHLETE Ad Libitum Fluid Intake
No restriction on fluid intake
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Transdermal Optical Imaging (TOI) signals
Blood flow patterns of the face obtained from the video camera on a smart phone
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
Standard measurement of hydration status: Body mass change
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
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
Standard measurements of hydration status: Urine specific gravity
Digital pen refractometer (Atago, PEN-Urine SG)
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
Standard measurements of hydration status: Urine color
Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
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
Standard measurements of hydration status: Thirst
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Subject demographics - Age
in years
At screening
Subject demographics - Sex
male or female
At screening
Subject demographics - Ethnicity
Hispanic or Latino, or not Hispanic or Latino
At screening
Subject demographics - Race
American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White
At screening
Fitzpatrick classification of skin color
Skin type from 1=White skin, always burns, never tans to 6 = Black skin, heavily pigmented, never burns, tans very easily
At screening
Mood scale
Rated from 1=Calm to 9=Irritated
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
Dietary and fluid intake
Food and fluid intake recorded on a paper log
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)
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
14 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

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

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)

PepsiCo Global R&D logoPepsiCo Global R&D
Study Central Contact
Contact: Matthew Hinkley, PhD, 914-742-4975, [email protected]
4 Study Locations in 1 Countries

Florida

Pepsico R&D Life Sciences, Bradenton, Florida, 34210, United States
Khalil Lee, PhD, Contact, 334-728-0250, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruiting

Illinois

PepsiCo R&D Gatorade Sports Science Institute, Chicago, Illinois, 60607, United States
Shellen Goltz, PhD, Contact, 312-821-3317, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruiting

New York

PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, 10595, United States
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Matthew Hinkley, PhD, Principal Investigator
Recruiting

Texas

PepsiCo R&D, Gatorade Sports Science Institute, Plano, Texas, 75024, United States
Anthony Wolfe, MS, Contact, 469-920-2862, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruiting