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De klinische studie NCT06212518 voor Uitdroging is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
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De klinische studie NCT06212518 is een interventioneel studie bij Uitdroging met de status recruterend. Het doel is om 1.000 deelnemers te includeren vanaf 2 oktober 2023. De studie wordt geleid door PepsiCo Global R&D en de voltooiing is gepland op 31 augustus 2024. Laatste update op ClinicalTrials.gov: 19 januari 2024.
Beknopte samenvatting
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.
Officiële titel
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
Aandoeningen
UitdrogingAndere studie-ID's
- PEP-2306 3b
NCT-ID
Startdatum (Werkelijk)
2023-10-02
Laatste update geplaatst
2024-01-19
Verwachte einddatum
2024-08-31
Inschrijving (Geschat)
1.000
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
Primaire doel
Basiswetenschap
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelGENPOP 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)). |
ExperimenteelGENPOP ad libitum fluid intake No fluid restriction | GENPOP Ad Libitum Fluid Intake Unrestricted fluid intake. |
ExperimenteelATHLETE 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. |
ExperimenteelATHLETE 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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Transdermal Optical Imaging (TOI) signals | Blood flow patterns of the face obtained from the video camera on a smart phone | 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 | Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg) | 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 | Digital pen refractometer (Atago, PEN-Urine SG) | 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 | Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7 | 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 | Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty | 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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Subject demographics - Age | in years | At screening |
Subject demographics - Sex | male or female | At screening |
Subject demographics - Ethnicity | Hispanic or Latino, or not Hispanic or Latino | At screening |
Subject demographics - Race | American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White | At screening |
Fitzpatrick classification of skin color | Skin type from 1=White skin, always burns, never tans to 6 = Black skin, heavily pigmented, never burns, tans very easily | At screening |
Mood scale | Rated from 1=Calm to 9=Irritated | 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 |
Dietary and fluid intake | Food and fluid intake recorded on a paper log | For GENPOP from 24 hours prior to Day 1 visit (~8 a.m.) through end of testing period (Day 2 ~8 a.m.). For ATHLETES from 24 hours to prior to start of single ~45 minute exercise session (if fluid restricted) or to end of exercise (if ad lib fluid intake) |
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
14 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
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
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)
PepsiCo Global R&DCentraal Contactpersoon
Contact: Matthew Hinkley, PhD, 914-742-4975, [email protected]
4 Studielocaties in 1 landen
Florida
Pepsico R&D Life Sciences, Bradenton, Florida, 34210, United States
Khalil Lee, PhD, Contact, 334-728-0250, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruterend
Illinois
PepsiCo R&D Gatorade Sports Science Institute, Chicago, Illinois, 60607, United States
Shellen Goltz, PhD, Contact, 312-821-3317, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruterend
New York
PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, 10595, United States
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Matthew Hinkley, PhD, Hoofdonderzoeker
Recruterend
Texas
PepsiCo R&D, Gatorade Sports Science Institute, Plano, Texas, 75024, United States
Anthony Wolfe, MS, Contact, 469-920-2862, [email protected]
Matthew Hinkley, PhD, Contact, 914-742-4975, [email protected]
Recruterend