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GENPOP passive dehydration for Dehydration

N/A

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

Awards & highlights

Study Summary

This trial will explore using smart phone-based TOI to detect dehydration in the general population and after exercise. TOI data will be compared to standard reference measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ genpop: before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~genpop: before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day

This trial's timeline: 3 weeks for screening, Varies for treatment, and genpop: before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day 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 measurements of hydration status

Transdermal optical imaging (TOI) signals

Secondary outcome measures

Demographics

Dietary and fluid intake

EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy

+13 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: GENPOP passive dehydrationExperimental Treatment1 Intervention

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

Group II: GENPOP ad lib fluid intakeExperimental Treatment1 Intervention

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

Group III: EXERCISE without fluid replacementExperimental Treatment1 Intervention

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.

Group IV: EXERCISE with fluid replacementExperimental Treatment1 Intervention

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Who is running the clinical trial?

PepsiCo Global R&DLead Sponsor

89 Previous Clinical Trials

12,629 Total Patients Enrolled

1 Trials studying Dehydration

1,000 Patients Enrolled for Dehydration

Lindsay Baker, PhDStudy DirectorPepsiCo, Inc. Sports Science

3 Previous Clinical Trials

1,215 Total Patients Enrolled

1 Trials studying Dehydration

1,000 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.

Is the upper age limit for participants in this experiment greater than 25 years?

"The enrollment criteria for this trial restricts applicants to those between 18 and 65 years old."

Answered by AI

Could I participate in this study?

"To be eligible for this experiment, individuals must experience dehydration and fall within the age parameter of 18 to 65. The total number of participants accepted is 35."

Answered by AI

Is registration for this trial still open?

"Affirmative. Clinicaltrials.gov contains evidence that this experiment is open to new participants, and was first posted on May 8th 2023 with the most recent update occurring September 13th 2023. The study aims to recruit 35 individuals from 2 sites."

Answered by AI

How many individuals have participated in the experiment thus far?

"Affirmative. Evidence posting on clinicaltrials.gov suggests that this trial, which was inaugurated on May 8th 2023, is presently recruiting patients. A total of 35 participants need to be enrolled from 2 distinct centres."

Answered by AI

What specific outcome is this trial attempting to ascertain?

"The purpose of this clinical investigation is to objectively assess the impact of GENPOP and EXERCISE on hydration status. Other metrics being monitored include Fitzpatrick Scale, Mood Scale, and Dietary/Fluid intake over a defined time period that includes pre-breakfast (~8am), pre-lunch (11:30 am), post-lunch (3:30 pm) 8am the following day with an added 30 minute cool down interval for exercise sessions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development

2023. "Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044610.