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

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044610
• Other study ID #: PEP-2306 3a
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration

Intervention

Other:
• GENPOP Passive dehydration (75% reduction in fluid intake
Over 24-hours
• GENPOP Ad lib fluid intake
Over 24 hours
• EXERCISE without fluid replacement
90-min standard cycling exercise trial in heat chamber
• EXERCISE with fluid replacement
90-min standard cycling exercise trial in heat chamber

Locations

Country	Name	City	State
United States	PepsiCo R&D, Gatorade Sports Science Institute	Plano	Texas
United States	PepsiCo R&D, Gatorade Sports Science Institute	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Demographics	Age, sex, ethnicity, race	At screening
Secondary	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
Secondary	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
Secondary	Dietary and fluid intake	Log entries of food and drink	24 hours prior to each visit through end of each study period.
Secondary	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
Secondary	EXERCISE only: Heart rate	(beats/min)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Secondary	EXERCISE only: Work rate	(watts, rpm)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Secondary	EXERCISE only: Fluid intake (euhydrated state)	(fluid volume in milliliters)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EXERCISE only: Sweat biomarkers	(electrolyte and metabolites)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Secondary	EXERCISE only: Saliva biomarkers	(osmolality and metabolites)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Secondary	EXERCISE only: Fingertip capillary blood biomarkers	(electrolytes and osmolality)	Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days