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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 hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status.
This is an exploratory pilot proof of concept study with each subject serving as their own control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENPOP passive dehydration | Experimental | 24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees. |
|
| EXERCISE without fluid replacement | Experimental | Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst. |
|
| GENPOP ad lib fluid intake | Other | 24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees. |
|
| EXERCISE with fluid replacement | Other | Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENPOP Passive dehydration (75% reduction in fluid intake | Other | Over 24-hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transdermal optical imaging (TOI) signals | Blood flow patterns of the face obtained from the video camera on a smart phone | GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise session allowing for 30 minute cool down period. |
| Standard measurements of hydration status | Body mass change, urine specific gravity, urine color (1-8 scale), and visual analogue scale to indicate thirst (1=not thirsty at all to 7 very, very thirsty) | GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise sessions allowing for 30 minute cool down period. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Age, sex, ethnicity, race | At screening |
| Fitzpatrick scale | Classification of skin type 1 through 6, 1=White skin. Always burns, never tans, to 6=Black skin. Heavily pigmented. Never burns, tans very easily. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay Baker, PhD | PepsiCo, Inc. Sports Science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PepsiCo R&D, Gatorade Sports Science Institute | Valhalla | New York | 10595 | United States | ||
| PepsiCo R&D, Gatorade Sports Science Institute |
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| GENPOP Ad lib fluid intake | Other | Over 24 hours |
|
| EXERCISE without fluid replacement | Other | 90-min standard cycling exercise trial in heat chamber |
|
| EXERCISE with fluid replacement | Other | 90-min standard cycling exercise trial in heat chamber |
|
| At screening |
| Mood scale | 9-point categorical scale from 1 (calm) to 9 (irritated) | GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day |
| Dietary and fluid intake | Log entries of food and drink | 24 hours prior to each visit through end of each study period. |
| EXERCISE only: Rate of perceived exertion (RPE) | Borg scale (6-20 scale) from no exertion at all to maximal exertion | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Heart rate | (beats/min) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Work rate | (watts, rpm) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Fluid intake (euhydrated state) | (fluid volume in milliliters) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Sweating rate | Rate of sweat over the course of the testing session. | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy | Measured on staff iPad or iPhone to extract facial movements & voice quality features | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Physical and mental energy | Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always. | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Grittiness score | 8 item grit scale (examples: ideas, setbacks, goals) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Visual analogue scale for mental energy and fatigue | Marked on a horizontal line anchored by 0-100 mm with 0 (no energy and fatigue) to 100 mm (strongest feeling of energy and strongest feeling of fatigue ever felt) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Sweat biomarkers | (electrolyte and metabolites) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Saliva biomarkers | (osmolality and metabolites) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| EXERCISE only: Fingertip capillary blood biomarkers | (electrolytes and osmolality) | Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days |
| Plano |
| Texas |
| 75024 |
| United States |
| 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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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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