Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development

Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a 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 hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status.

This is an exploratory pilot proof of concept study with each subject serving as their own control.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Other: GENPOP Passive dehydration (75% reduction in fluid intake; Other: EXERCISE without fluid replacement; Other: GENPOP Ad lib fluid intake; Other: EXERCISE with fluid replacement

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • PepsiCo R&D, Gatorade Sports Science Institute
  • Texas
    • Plano, Texas, United States, 75024
      • PepsiCo R&D, Gatorade Sports Science Institute

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject is male or female
• If female, subject is not pregnant
• For GENPOP study subject is 18-65 years of age, inclusive
• For EXERCISE study subject is 18-50 years of age, inclusive
• Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 1 hour at a time (EXERCISE session participants only)
• 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 avoid alcohol consumption 24 hours prior to visit(s)
• Subject is willing to fast overnight (~8-12 hours)
• For GENPOP, subject is willing to refrain from vigorous exercise for 48 hours
• For EXERCISE, subject is willing to refrain from vigorous exercise for 24 hours prior to study visits
• Subject is willing to eat the exact same food the day prior to each visit to the laboratory
• Subject is willing to avoid wearing makeup to the study session
• 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

Exclusion Criteria:

• Subject has participated 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 has a history of anaphylaxis or severe allergic reactions
• Subjects has a health condition or is taking medication that can be worsened by fluid restriction
• Subject has asthma or other condition which breathing can become labored during exercise (EXERCISE session participants only)
• Male subjects with a VO2max < 42 ml/kg/min and females with a VO2max < 38 ml/kg/min (EXERCISE session participants only)
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GENPOP passive dehydration; 24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.	Other: GENPOP Passive dehydration (75% reduction in fluid intake; Over 24-hours
Experimental: EXERCISE without fluid replacement; Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.	Other: EXERCISE without fluid replacement; 90-min standard cycling exercise trial in heat chamber
Other: GENPOP ad lib fluid intake; 24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.	Other: GENPOP Ad lib fluid intake; Over 24 hours
Other: EXERCISE with fluid replacement; Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.	Other: EXERCISE with fluid replacement; 90-min standard cycling exercise trial in heat chamber

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	GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise session allowing for 30 minute cool down period.
Standard measurements of hydration status	Body mass change, urine specific gravity, urine color (1-8 scale), and visual analogue scale to indicate thirst (1=not thirsty at all to 7 very, very thirsty)	GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise sessions allowing for 30 minute cool down period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Age, sex, ethnicity, race	At screening
Fitzpatrick scale	Classification of skin type 1 through 6, 1=White skin. Always burns, never tans, to 6=Black skin. Heavily pigmented. Never burns, tans very easily.	At screening
Mood scale	9-point categorical scale from 1 (calm) to 9 (irritated)	GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day
Dietary and fluid intake	Log entries of food and drink	24 hours prior to each visit through end of each study period.
EXERCISE only: Rate of perceived exertion (RPE)	Borg scale (6-20 scale) from no exertion at all to maximal exertion	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Heart rate	(beats/min)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Work rate	(watts, rpm)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fluid intake (euhydrated state)	(fluid volume in milliliters)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Sweating rate	Rate of sweat over the course of the testing session.	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy	Measured on staff iPad or iPhone to extract facial movements & voice quality features	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Physical and mental energy	Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Grittiness score	8 item grit scale (examples: ideas, setbacks, goals)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Visual analogue scale for mental energy and fatigue	Marked on a horizontal line anchored by 0-100 mm with 0 (no energy and fatigue) to 100 mm (strongest feeling of energy and strongest feeling of fatigue ever felt)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Sweat biomarkers	(electrolyte and metabolites)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Saliva biomarkers	(osmolality and metabolites)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fingertip capillary blood biomarkers	(electrolytes and osmolality)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Study Director: Lindsay Baker, PhD, PepsiCo, Inc. Sports Science

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 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 3a

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