RECRUITING

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

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Conditions

DehydrationhydrationeuhydrationhypohydrationexerciseTransdermal Optical ImagingTOI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-10-02
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06212518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is male or female
  2. * If female, subject is not pregnant
  3. * Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
  4. * Subject is willing to avoid wearing makeup to the study session or willing to remove it with facial wipes before the face scans
  5. * Subject is willing to shave facial hair if predetermined during the informed consent session it will interfere with TOI measurement
  6. * Able to speak, write, and read English
  7. * Provision of written consent to participate
  8. * Study subject is 18-65 years of age, inclusive
  9. * Subject does not smoke (or has quit for at least 6 months)
  10. * Subject is not taking medication that may interfere with the study
  11. * Subject has no health conditions that would prevent completion of the trial as indicated on the general health questionnaire (GHQ)
  12. * Subject is willing to fast overnight (\~8-12 hours)
  13. * Subject is willing to refrain from vigorous exercise for 48 hours
  14. * Subject is willing to eat the exact same food the day prior to each visit to the testing site
  15. * Study subject is 14-45 years of age, inclusive
  16. * Subject is participating in team sport training/competition
  17. * Subject is participating in a coach-led practice
  1. * Subject has participated or currently enrolled in a clinical trial within the past 30 days
  2. * Subject has participated in any PepsiCo trial within past 6 months
  3. * 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
  4. * Subject is allergic to alcohol or facial cleansing wipes
  5. * 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.

Contacts and Locations

Study Contact

Matthew Hinkley, PhD
CONTACT
914-742-4975
Matt.Hinkley@pepsico.com

Principal Investigator

Lindsay Baker, PhD
STUDY_DIRECTOR
PepsiCo, Inc. Sports Science
Matt Hinkley, PhD
PRINCIPAL_INVESTIGATOR
Pepsico, Inc. Sports Science

Study Locations (Sites)

Pepsico R&D Life Sciences
Bradenton, Florida, 34210
United States
PepsiCo R&D Gatorade Sports Science Institute
Chicago, Illinois, 60607
United States
PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, 10595
United States
PepsiCo R&D, Gatorade Sports Science Institute
Plano, Texas, 75024
United States

Collaborators and Investigators

Sponsor: PepsiCo Global R&D

  • Lindsay Baker, PhD, STUDY_DIRECTOR, PepsiCo, Inc. Sports Science
  • Matt Hinkley, PhD, PRINCIPAL_INVESTIGATOR, Pepsico, Inc. Sports Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Dehydration