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GENPOP passive dehydration for Dehydration

N/A
Recruiting
Led By Matt Hinkley, PhD
Research Sponsored by PepsiCo Global R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female, subject is not pregnant
ATHLETE Study: Study subject is 14-45 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening
Awards & highlights

Study Summary

This trial aims to use a smartphone app to analyze skin images and develop a model that can determine hydration levels in both healthy adults and athletes. The study will collect data from participants and compare it to standard

Who is the study for?
This trial is for healthy adults and athletes who want to help test a new way of measuring hydration using a smartphone app. Participants will either limit their fluid intake or drink as much as they want, at different times over 24 hours or around a sports training session.Check my eligibility
What is being tested?
The study is testing Transdermal Optical Imaging (TOI) technology in two groups: general population and athletes. It aims to see if the TOI can accurately tell how hydrated someone is by comparing it with standard methods, during normal activities and after exercise.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring with a smartphone app and changes in water consumption, there are no direct side effects from any medication or intervention being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant.
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I am between 14 and 45 years old.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Standard measurement of hydration status: Body mass change
Standard measurements of hydration status: Thirst
Standard measurements of hydration status: Urine color
+2 more
Secondary outcome measures
Dietary and fluid intake
Fitzpatrick classification of skin color
Mood scale
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: GENPOP passive dehydrationExperimental Treatment1 Intervention
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.
Group II: GENPOP ad libitum fluid intakeExperimental Treatment1 Intervention
No fluid restriction
Group III: ATHLETE with fluid restrictionExperimental Treatment1 Intervention
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.
Group IV: ATHLETE ad libitum fluid intakeExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

PepsiCo Global R&DLead Sponsor
89 Previous Clinical Trials
11,661 Total Patients Enrolled
1 Trials studying Dehydration
32 Patients Enrolled for Dehydration
Matt Hinkley, PhDPrincipal InvestigatorPepsico, Inc. Sports Science
Lindsay Baker, PhDStudy DirectorPepsiCo, Inc. Sports Science
3 Previous Clinical Trials
247 Total Patients Enrolled
1 Trials studying Dehydration
32 Patients Enrolled for Dehydration

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are above the age of 50 eligible to participate in this medical study?

"To be eligible for this clinical trial, patients must fall within the age range of 14 to 65. Additionally, there are a total of 5 trials specifically designed for participants under the age of 18 and another 7 trials targeting individuals over the age of 65."

Answered by AI

Which individuals meet the criteria for inclusion in this medical study?

"To be eligible for participation in this clinical trial, candidates must meet the following criteria: they should have dehydration as a medical condition and fall within the age range of 14 to 65 years. The study aims to enroll a total of 1000 eligible candidates."

Answered by AI

How many participants are currently undergoing treatment in this medical study?

"To successfully carry out this study, a total of 1000 eligible participants who meet the inclusion criteria are required. PepsiCo Global R&D, the sponsor of this trial, will be overseeing it across different sites including Pepsico R&D Life Sciences in Bradenton, Florida and PepsiCo R&D Gatorade Sports Science Institute in Chicago, Illinois."

Answered by AI

Are patients currently able to enroll in this ongoing medical study?

"Indeed, the data available on clinicaltrials.gov affirms that this clinical trial is presently in the process of enrolling patients. The initial posting date for this study was October 2nd, 2023 and it was last updated on January 13th, 2024. A total of four locations are involved in recruiting approximately 1000 participants for this trial."

Answered by AI

Are there numerous medical facilities within the United States participating in this clinical trial?

"At present, this trial is ongoing at 4 sites. These include Bradenton, Chicago, Valhalla, and an additional 4 undisclosed locations. To minimize travel commitments for participants, it would be advisable to choose the clinic closest to their residence when enrolling in the study."

Answered by AI

Who else is applying?

What site did they apply to?
PepsiCo R&D, Gatorade Sports Science Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking to help out the cause.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
2023. "Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212518.
All > Dehydration > Fort Worth
~400 spots leftby Aug 2024
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