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

PepsiCo

Status: Enrolling

Conditions: Dehydration

Treatments: Other: GENPOP fluid restriction; Other: ATHLETE restricted fluid intake; Other: GENPOP ad libitum fluid intake; Other: ATHLETE ad libitum fluid intake

Study type: Interventional

Funder types: Industry

Identifiers

NCT06212518

PEP-2306 3b

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 4 patient groups

GENPOP passive dehydration

Experimental group

Description:

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.

Treatment:

Other: GENPOP fluid restriction

GENPOP ad libitum fluid intake

Experimental group

Description:

No fluid restriction

Treatment:

Other: GENPOP ad libitum fluid intake

ATHLETE with fluid restriction

Experimental group

Description:

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.

Treatment:

Other: ATHLETE restricted fluid intake

ATHLETE ad libitum fluid intake

Experimental group

Description:

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.

Treatment:

Other: ATHLETE ad libitum fluid intake