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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dehydration

Intervention / Treatment
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* Other: GENPOP Passive dehydration (75% reduction in fluid intake
* Other: GENPOP Ad lib fluid intake
* Other: EXERCISE without fluid replacement
* Other: EXERCISE with fluid replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GENPOP passive dehydration<br>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<br>* Over 24-hours<br>|
| Experimental: EXERCISE without fluid replacement<br>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<br>* 90-min standard cycling exercise trial in heat chamber<br>|
| Other: GENPOP ad lib fluid intake<br>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<br>* Over 24 hours<br>|
| Other: EXERCISE with fluid replacement<br>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<br>* 90-min standard cycling exercise trial in heat chamber<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOI, hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging