Recruiting

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

Sponsor:

PepsiCo Global R&D

Code:

NCT06212518

Conditions

Dehydration

Eligibility Criteria

Sex: All

Age: 14 - 65

Healthy Volunteers: Accepted

Interventions

GENPOP ad libitum fluid intake

GENPOP fluid restriction

ATHLETE ad libitum fluid intake

ATHLETE restricted fluid intake

Study Details

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

Study ID

NCT06212518

Start date

Oct 2, 2023

Status verified date

Jan, 2024

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 14 - 65

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: GENPOP passive dehydration

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.

experimental: GENPOP ad libitum fluid intake

No fluid restriction

experimental: ATHLETE with fluid restriction

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.

experimental: ATHLETE ad libitum fluid intake

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.

Interventions

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.

Primary outcome measure

Transdermal Optical Imaging (TOI) signals [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Matthew Hinkley, PhD

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

Locations

Pepsico R&D Life Sciences

Recruiting

Bradenton, Florida, United States, 34210

Contacts

Khalil Lee, PhD

334-728-0250 khalil.Lee@pepsico.com

Matthew Hinkley, PhD

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

PepsiCo R&D Gatorade Sports Science Institute

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Shellen Goltz, PhD

312-821-3317 Shellen.Goltz@pepsico.com

Matthew Hinkley, PhD

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

PepsiCo R&D, Gatorade Sports Science Institute

Recruiting

Valhalla, New York, United States, 10595

Contacts

Matthew Hinkley, PhD

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

Principal Investigator:

Matthew Hinkley, PhD

PepsiCo R&D, Gatorade Sports Science Institute

Recruiting

Plano, Texas, United States, 75024

Contacts

Anthony Wolfe, MS

469-920-2862 Anthony.Wolfe@pepsico.com

Matthew Hinkley, PhD

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

More Information

Sponsor

PepsiCo Global R&D

Last update posted

Jan 19, 2024

Last verified

Jan, 2024

Keywords

hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PepsiCo Global R&D on 2024-01-19.