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

Primary Purpose

Dehydration

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GENPOP Passive dehydration (75% reduction in fluid intake
GENPOP Ad lib fluid intake
EXERCISE without fluid replacement
EXERCISE with fluid replacement
Sponsored by
PepsiCo Global R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration focused on measuring hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PepsiCo R&D, Gatorade Sports Science InstituteRecruiting
  • PepsiCo R&D, Gatorade Sports Science InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

GENPOP passive dehydration

EXERCISE without fluid replacement

GENPOP ad lib fluid intake

EXERCISE with fluid replacement

Arm Description

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

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.

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

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.

Outcomes

Primary Outcome Measures

Transdermal optical imaging (TOI) signals
Blood flow patterns of the face obtained from the video camera on a smart phone
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)

Secondary Outcome Measures

Demographics
Age, sex, ethnicity, race
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.
Mood scale
9-point categorical scale from 1 (calm) to 9 (irritated)
Dietary and fluid intake
Log entries of food and drink
EXERCISE only: Rate of perceived exertion (RPE)
Borg scale (6-20 scale) from no exertion at all to maximal exertion
EXERCISE only: Heart rate
(beats/min)
EXERCISE only: Work rate
(watts, rpm)
EXERCISE only: Fluid intake (euhydrated state)
(fluid volume in milliliters)
EXERCISE only: Sweating rate
Rate of sweat over the course of the testing session.
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
EXERCISE only: Physical and mental energy
Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.
EXERCISE only: Grittiness score
8 item grit scale (examples: ideas, setbacks, goals)
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)
EXERCISE only: Sweat biomarkers
(electrolyte and metabolites)
EXERCISE only: Saliva biomarkers
(osmolality and metabolites)
EXERCISE only: Fingertip capillary blood biomarkers
(electrolytes and osmolality)

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
PepsiCo Global R&D
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1. Study Identification

Unique Protocol Identification Number
NCT06044610
Brief Title
Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
Official Title
Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepsiCo Global R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GENPOP passive dehydration
Arm Type
Experimental
Arm Description
24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
Arm Title
EXERCISE without fluid replacement
Arm Type
Experimental
Arm Description
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.
Arm Title
GENPOP ad lib fluid intake
Arm Type
Other
Arm Description
24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
Arm Title
EXERCISE with fluid replacement
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
GENPOP Passive dehydration (75% reduction in fluid intake
Intervention Description
Over 24-hours
Intervention Type
Other
Intervention Name(s)
GENPOP Ad lib fluid intake
Intervention Description
Over 24 hours
Intervention Type
Other
Intervention Name(s)
EXERCISE without fluid replacement
Intervention Description
90-min standard cycling exercise trial in heat chamber
Intervention Type
Other
Intervention Name(s)
EXERCISE with fluid replacement
Intervention Description
90-min standard cycling exercise trial in heat chamber
Primary Outcome Measure Information:
Title
Transdermal optical imaging (TOI) signals
Description
Blood flow patterns of the face obtained from the video camera on a smart phone
Time Frame
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.
Title
Standard measurements of hydration status
Description
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)
Time Frame
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 Measure Information:
Title
Demographics
Description
Age, sex, ethnicity, race
Time Frame
At screening
Title
Fitzpatrick scale
Description
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.
Time Frame
At screening
Title
Mood scale
Description
9-point categorical scale from 1 (calm) to 9 (irritated)
Time Frame
GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day
Title
Dietary and fluid intake
Description
Log entries of food and drink
Time Frame
24 hours prior to each visit through end of each study period.
Title
EXERCISE only: Rate of perceived exertion (RPE)
Description
Borg scale (6-20 scale) from no exertion at all to maximal exertion
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Heart rate
Description
(beats/min)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Work rate
Description
(watts, rpm)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Fluid intake (euhydrated state)
Description
(fluid volume in milliliters)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Sweating rate
Description
Rate of sweat over the course of the testing session.
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy
Description
Measured on staff iPad or iPhone to extract facial movements & voice quality features
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Physical and mental energy
Description
Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Grittiness score
Description
8 item grit scale (examples: ideas, setbacks, goals)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Visual analogue scale for mental energy and fatigue
Description
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)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Sweat biomarkers
Description
(electrolyte and metabolites)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Saliva biomarkers
Description
(osmolality and metabolites)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Title
EXERCISE only: Fingertip capillary blood biomarkers
Description
(electrolytes and osmolality)
Time Frame
Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Hinkley, PhD
Phone
914-742-4975
Email
Matt.Hinkley@pepsico.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Baker, PhD
Organizational Affiliation
PepsiCo, Inc. Sports Science
Official's Role
Study Director
Facility Information:
Facility Name
PepsiCo R&D, Gatorade Sports Science Institute
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Hinkley, PhD
Phone
914-742-4975
Email
Matt.Hinkley@pepsico.com
First Name & Middle Initial & Last Name & Degree
Matthew Hinkley, PhD
Facility Name
PepsiCo R&D, Gatorade Sports Science Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Wolfe, M.S.
Phone
574-315-5901
Email
Anthony.Wolfe@pepsico.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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