GENPOP Passive dehydration (75% reduction in fluid intake
OtherOver 24-hours
NCT Number: NCT06044610
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Over 24-hours
Over 24 hours
90-min standard cycling exercise trial in heat chamber
90-min standard cycling exercise trial in heat chamber
Time frame: 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.
Blood flow patterns of the face obtained from the video camera on a smart phone
Time frame: 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.
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)
Time frame: At screening
Age, sex, ethnicity, race
Time frame: At screening
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.
Time frame: GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day
9-point categorical scale from 1 (calm) to 9 (irritated)
Time frame: 24 hours prior to each visit through end of each study period.
Log entries of food and drink
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Borg scale (6-20 scale) from no exertion at all to maximal exertion
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(beats/min)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(watts, rpm)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(fluid volume in milliliters)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Rate of sweat over the course of the testing session.
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Measured on staff iPad or iPhone to extract facial movements & voice quality features
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
8 item grit scale (examples: ideas, setbacks, goals)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
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)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(electrolyte and metabolites)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(osmolality and metabolites)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
(electrolytes and osmolality)
PepsiCo Global R&D
Industry
Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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