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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENPOP passive dehydration | Experimental | 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 | Experimental | No fluid restriction |
|
| ATHLETE with fluid restriction | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENPOP ad libitum fluid intake | Other | Unrestricted fluid intake. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject demographics - Age | in years | At screening |
| Subject demographics - Sex | male or female | At screening |
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Inclusion Criteria:
Both Study Arms (GENPOP and ATHLETE)
GENPOP Study
ATHLETE Study
Exclusion Criteria:
Both Study Arms (GENPOP and ATHLETE)
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Hinkley, PhD | Contact | 914-742-4975 | Matt.Hinkley@pepsico.com |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Baker, PhD | PepsiCo, Inc. Sports Science | Study Director |
| Matt Hinkley, PhD | Pepsico, Inc. Sports Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pepsico R&D Life Sciences | Recruiting | Bradenton | Florida | 34210 | United States |
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| GENPOP fluid restriction |
| Other |
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 | Other | No restriction on fluid intake |
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| ATHLETE restricted fluid intake | Other | Not permitted to drink during training session. |
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| 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) |
| PepsiCo R&D Gatorade Sports Science Institute | Recruiting | Chicago | Illinois | 60607 | United States |
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| PepsiCo R&D, Gatorade Sports Science Institute | Recruiting | Valhalla | New York | 10595 | United States |
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| PepsiCo R&D, Gatorade Sports Science Institute | Recruiting | Plano | Texas | 75024 | United States |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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