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

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.

Study Overview

• Status: Recruiting
• Conditions: Dehydration
• Intervention / Treatment: Other: GENPOP fluid restriction; Other: GENPOP ad libitum fluid intake; Other: ATHLETE restricted fluid intake; Other: ATHLETE ad libitum fluid intake

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Hinkley, PhD; Phone Number: 914-742-4975; Email: Matt.Hinkley@pepsico.com

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34210
      • Recruiting
      • PepsiCo R&D Life Sciences
      • Contact: Matthew Hinkley, PhD; Phone Number: 914-742-4975; Email: Matt.Hinkley@pepsico.com
      • Contact: Khalil Lee, PhD; Phone Number: 334-728-0250; Email: khalil.Lee@pepsico.com
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Recruiting
      • PepsiCo R&D Gatorade Sports Science Institute
      • Contact: Matthew Hinkley, PhD; Phone Number: 914-742-4975; Email: Matt.Hinkley@pepsico.com
      • Contact: Shellen Goltz, PhD; Phone Number: 312-821-3317; Email: Shellen.Goltz@pepsico.com
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • PepsiCo R&D, Gatorade Sports Science Institute
      • Contact: Matthew Hinkley, PhD; Phone Number: 914-742-4975; Email: Matt.Hinkley@pepsico.com
      • Principal Investigator: Matthew Hinkley, PhD
  • Texas
    • Plano, Texas, United States, 75024
      • Recruiting
      • PepsiCo R&D, Gatorade Sports Science Institute
      • Contact: Matthew Hinkley, PhD; Phone Number: 914-742-4975; Email: Matt.Hinkley@pepsico.com
      • Contact: Anthony Wolfe, MS; Phone Number: 469-920-2862; Email: Anthony.Wolfe@pepsico.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GENPOP 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.	Other: 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)).
Experimental: GENPOP ad libitum fluid intake; No fluid restriction	Other: GENPOP ad libitum fluid intake; Unrestricted fluid intake.
Experimental: ATHLETE 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.	Other: ATHLETE restricted fluid intake; Not permitted to drink during training session.
Experimental: ATHLETE 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.	Other: ATHLETE ad libitum fluid intake; No restriction on fluid intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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)

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Study Director: Lindsay Baker, PhD, PepsiCo, Inc. Sports Science; Principal Investigator: Matt Hinkley, PhD, PepsiCo, Inc. Sports Science

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 13, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: exercise; dehydration; hydration; hypohydration; euhydration; Transdermal Optical Imaging; TOI
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: PEP-2306 3b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No