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

Last updated: January 13, 2024
Sponsor: PepsiCo Global R&D
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

GENPOP fluid restriction

ATHLETE restricted fluid intake

ATHLETE ad libitum fluid intake

Clinical Study ID

NCT06212518
PEP-2306 3b
  • Ages 14-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 removeit with facial wipes before the face scans
  • Subject is willing to shave facial hair if predetermined during the informed consentsession 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 asindicated 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 thetesting 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

Exclusion Criteria: Both Study Arms (GENPOP and ATHLETE)

  • Subject has participated or currently enrolled in a clinical trial within the past 30days
  • Subject has participated in any PepsiCo trial within past 6 months
  • Subject has a condition or is taking medication that the investigator believes wouldinterfere with his/her ability to provide informed consent, comply with the studyprotocol, which might confound the interpretation of the study results, or put theperson 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 memberemployed by a company that manufactures any products that compete with any Gatoradeproduct. If subject is unsure if a company would be considered a competitor toGatorade, they will be asked to please let the study investigator know the name of theother company and the nature of their relationship to that company before they signthe informed consent. GENPOP Study

• Subject has a health condition or is taking medication that can be worsened by fluidrestriction (participants who opt-in to fluid restriction study arm only)

Study Design

Total Participants: 1000
Treatment Group(s): 4
Primary Treatment: GENPOP fluid restriction
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Pepsico R&D Life Sciences

    Bradenton, Florida 34210
    United States

    Active - Recruiting

  • PepsiCo R&D Gatorade Sports Science Institute

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • PepsiCo R&D, Gatorade Sports Science Institute

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • PepsiCo R&D, Gatorade Sports Science Institute

    Plano, Texas 75024
    United States

    Active - Recruiting

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