Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
NCT ID: NCT06212518
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-10-02
2024-08-31
Brief Summary
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In this study each subject will serve as their own control.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
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)).
GENPOP ad libitum fluid intake
No fluid restriction
GENPOP ad libitum fluid intake
Unrestricted fluid intake.
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.
ATHLETE restricted fluid intake
Not permitted to drink during training session.
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.
ATHLETE ad libitum fluid intake
No restriction on fluid intake
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
14 Years
65 Years
ALL
Yes
Sponsors
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PepsiCo Global R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsay Baker, PhD
Role: STUDY_DIRECTOR
PepsiCo, Inc. Sports Science
Matt Hinkley, PhD
Role: PRINCIPAL_INVESTIGATOR
Pepsico, Inc. Sports Science
Locations
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Pepsico R&D Life Sciences
Bradenton, Florida, United States
PepsiCo R&D Gatorade Sports Science Institute
Chicago, Illinois, United States
PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, United States
PepsiCo R&D, Gatorade Sports Science Institute
Plano, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PEP-2306 3b
Identifier Type: -
Identifier Source: org_study_id
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