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

NCT06212518 | Unknown

• 1 other identifier: PEP-2306 3b
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Dehydration

Keywords

hydration; dehydration; euhydration; hypohydration; exercise; Transdermal Optical Imaging; TOI

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Subject demographics - Age

  At screening

• Subject demographics - Sex

  At screening

• Subject demographics - Ethnicity

  At screening

• Subject demographics - Race

  At screening

• Fitzpatrick classification of skin color

  At screening

Study Arms (4)

GENPOP passive dehydration

EXPERIMENTAL

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)). Participants will be provided pre-filled water bottles and asked to only ingest fluid in bottle until second morning face scan.

Other: GENPOP fluid restriction

GENPOP ad libitum fluid intake

EXPERIMENTAL

No fluid restriction

Other: GENPOP ad libitum fluid intake

ATHLETE with fluid restriction

EXPERIMENTAL

For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Not permitted to drink during training session.

Other: ATHLETE restricted fluid intake

ATHLETE ad libitum fluid intake

EXPERIMENTAL

For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Permitted to drink during training session.

Other: ATHLETE ad libitum fluid intake

Interventions

GENPOP ad libitum fluid intake OTHER

Unrestricted fluid intake.

GENPOP ad libitum fluid intake

GENPOP fluid restriction OTHER

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)).

GENPOP passive dehydration

ATHLETE ad libitum fluid intake OTHER

No restriction on fluid intake

ATHLETE ad libitum fluid intake

ATHLETE restricted fluid intake OTHER

Not permitted to drink during training session.

ATHLETE with fluid restriction

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (4)

Pepsico R&D Life Sciences

Bradenton, Florida, 34210, United States

RECRUITING

PepsiCo R&D Gatorade Sports Science Institute

Chicago, Illinois, 60607, United States

RECRUITING

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

RECRUITING

PepsiCo R&D, Gatorade Sports Science Institute

Plano, Texas, 75024, United States

RECRUITING

MeSH Terms

Conditions

Dehydration; Motor Activity

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lindsay Baker, PhD

  PepsiCo, Inc. Sports Science

  STUDY DIRECTOR

• Matt Hinkley, PhD

  Pepsico, Inc. Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Hinkley, PhD

CONTACT

914-742-4975; Matt.Hinkley@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 19, 2024
• Study Start: October 2, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)