Dehydration
Conditions
Keywords
hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI
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.
Interventions
OTHERGENPOP ad libitum fluid intake
Unrestricted fluid intake.
OTHERGENPOP 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)).
OTHERATHLETE ad libitum fluid intake
No restriction on fluid intake
OTHERATHLETE restricted fluid intake
Not permitted to drink during training session.
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 - Age | At screening | in years |
| 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 |
| Subject demographics - Sex | At screening | male or female |
| Subject demographics - Ethnicity | At screening | Hispanic or Latino, or not Hispanic or Latino |
| Subject demographics - Race | At screening | American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White |
| 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 |
Countries
United States
Contacts
Primary ContactMatthew Hinkley, PhD
Outcome results
None listed