Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dehydration
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 1000
- Locations
- 3
- Primary Endpoint
- Standard measurements of hydration status: Thirst
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Standard measurements of hydration status: Thirst
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
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
Transdermal Optical Imaging (TOI) signals
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
Blood flow patterns of the face obtained from the video camera on a smart phone
Standard measurement of hydration status: Body mass change
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
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
Standard measurements of hydration status: Urine specific gravity
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
Digital pen refractometer (Atago, PEN-Urine SG)
Standard measurements of hydration status: Urine color
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
Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
Secondary Outcomes
- Subject demographics - Age(At screening)
- Subject demographics - Ethnicity(At screening)
- Subject demographics - Sex(At screening)
- 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))
- Fitzpatrick classification of skin color(At screening)
- 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)
- Subject demographics - Race(At screening)