An interventional study of GENPOP ad libitum fluid intake and GENPOP fluid restriction in Dehydration, sponsored by PepsiCo Global R&D. Recruiting at 4 sites in United States. Open to participants aged 14 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by PepsiCo Global R&D (part of PepsiCo, Inc.) · Not applicable, Interventional, and Basic science
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.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 43 across 145 interventional studies indexed under Dehydration.
Browse Dehydration studies →PepsiCo Global R&D is the lead sponsor of 103 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Both Study Arms (GENPOP and ATHLETE)
GENPOP Study
ATHLETE Study
Exclusion Criteria:
Both Study Arms (GENPOP and ATHLETE)
GENPOP Study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: GENPOP fluid restriction
No fluid restriction
Other: GENPOP ad libitum fluid intake
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.
Other: ATHLETE restricted fluid intake
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.
Other: ATHLETE ad libitum fluid intake
Unrestricted fluid intake.
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)).
No restriction on fluid intake
Not permitted to drink during training session.
Transdermal Optical Imaging (TOI) signals
Blood flow patterns of the face obtained from the video camera on a smart phone
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
Standard measurement of hydration status: Body mass change
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
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
Standard measurements of hydration status: Urine specific gravity
Digital pen refractometer (Atago, PEN-Urine SG)
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
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
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
Standard measurements of hydration status: Thirst
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
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
Subject demographics - Age
in years
Time frame: At screening
Subject demographics - Sex
male or female
Time frame: At screening
Subject demographics - Ethnicity
Hispanic or Latino, or not Hispanic or Latino
Time frame: At screening
Subject demographics - Race
American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White
Time frame: 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
Time frame: At screening
Mood scale
Rated from 1=Calm to 9=Irritated
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
Dietary and fluid intake
Food and fluid intake recorded on a paper log
Time frame: 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)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.