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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
1,000
Unrestricted fluid intake.
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)).
No restriction on fluid intake
Not permitted to drink during training session.
Pepsico R&D Life Sciences
Bradenton, Florida, United States
RECRUITINGPepsiCo R&D Gatorade Sports Science Institute
Chicago, Illinois, United States
RECRUITINGPepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, United States
RECRUITINGPepsiCo R&D, Gatorade Sports Science Institute
Plano, Texas, United States
RECRUITINGTransdermal Optical Imaging (TOI) signals
Blood flow patterns of the face obtained from the video camera on a smart phone
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Subject demographics - Age
in years
Time frame: At screening
Subject demographics - Sex
male or female
Time frame: At screening
Subject demographics - Ethnicity
Hispanic or Latino, or not Hispanic or Latino
Time frame: At screening
Subject demographics - Race
American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White
Time frame: 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
Time frame: At screening
Mood scale
Rated from 1=Calm to 9=Irritated
Time frame: 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
Time frame: 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)
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