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

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212518
• Other study ID #: PEP-2306 3b
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: PepsiCo Global R&D
• Contact: Matthew Hinkley, PhD
• Phone: 914-742-4975
• Email: Matt.Hinkley[@]pepsico.com
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dehydration

Intervention

Other:
• GENPOP ad libitum fluid intake
Unrestricted fluid intake.
• 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)).
• ATHLETE ad libitum fluid intake
No restriction on fluid intake
• ATHLETE restricted fluid intake
Not permitted to drink during training session.

Locations

Country	Name	City	State
United States	Pepsico R&D Life Sciences	Bradenton	Florida
United States	PepsiCo R&D Gatorade Sports Science Institute	Chicago	Illinois
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	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
Primary	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
Primary	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
Primary	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
Primary	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	Subject demographics - Age	in years	At screening
Secondary	Subject demographics - Sex	male or female	At screening
Secondary	Subject demographics - Ethnicity	Hispanic or Latino, or not Hispanic or Latino	At screening
Secondary	Subject demographics - Race	American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White	At screening
Secondary	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
Secondary	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
Secondary	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)