Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
- Conditions
- Dehydration
- Interventions
- Other: GENPOP fluid restrictionOther: GENPOP ad libitum fluid intakeOther: ATHLETE restricted fluid intakeOther: ATHLETE ad libitum fluid intake
- Registration Number
- NCT06212518
- Lead Sponsor
- PepsiCo Global R&D
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GENPOP passive dehydration 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)). Participants will be provided pre-filled water bottles and asked to only ingest fluid in bottle until second morning face scan. GENPOP ad libitum fluid intake GENPOP ad libitum fluid intake No fluid restriction ATHLETE with fluid restriction ATHLETE restricted 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. Not permitted to drink during training session. ATHLETE ad libitum fluid intake 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.
- Primary Outcome Measures
Name Time Method Standard measurements of hydration status: Thirst 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 Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
Transdermal Optical Imaging (TOI) signals 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 Blood flow patterns of the face obtained from the video camera on a smart phone
Standard measurement of hydration status: Body mass change 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 Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
Standard measurements of hydration status: Urine specific gravity 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 Digital pen refractometer (Atago, PEN-Urine SG)
Standard measurements of hydration status: Urine color 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 Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
- Secondary Outcome Measures
Name Time Method Subject demographics - Age At screening in years
Subject demographics - Ethnicity At screening Hispanic or Latino, or not Hispanic or Latino
Subject demographics - Sex At screening male or female
Dietary and fluid intake 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) Food and fluid intake recorded on a paper log
Fitzpatrick classification of skin color At screening Skin type from 1=White skin, always burns, never tans to 6 = Black skin, heavily pigmented, never burns, tans very easily
Mood scale 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 Rated from 1=Calm to 9=Irritated
Subject demographics - Race At screening American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White
Trial Locations
- Locations (3)
Pepsico R&D Life Sciences
🇺🇸Bradenton, Florida, United States
PepsiCo R&D, Gatorade Sports Science Institute
🇺🇸Plano, Texas, United States
PepsiCo R&D Gatorade Sports Science Institute
🇺🇸Chicago, Illinois, United States