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Electrolyte Solution
Beverage Composition for Fluid Balance
Saint Petersburg, FL
N/A
Recruiting
Led By Lawrence Galitz, MD
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
Subject is 18-50 years of age, inclusive
If female, subject is not pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit
Summary
This trial aims to investigate how the levels of sodium and glycerol in fluids affect the body's ability to retain water. The study will look at how different amounts of fluid intake impact overall fluid balance
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Who is the study for?
Healthy, active men and women aged 18-50 who don't smoke or take interfering medications can join this trial. They must not be pregnant, avoid alcohol before visits, fast overnight, refrain from vigorous exercise for a day prior, and eat the same food before each lab visit.Check my eligibility
What is being tested?
The study is testing how different electrolyte solutions with varying volumes and concentrations of glycerol affect fluid retention in the body. Participants will try several beverages to see which helps maintain fluid balance best without being lost through urination.See study design
What are the potential side effects?
Since this trial involves common beverage ingredients like sodium and glycerol in healthy individuals at rest, significant side effects are unlikely. However, participants may experience mild gastrointestinal discomfort or changes in urination patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
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I am not pregnant.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline (pre-beverage) to post-beverage time 30, 60, 90,120, 150,180 and 210 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (pre-beverage) to post-beverage time 30, 60, 90,120, 150,180 and 210 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fluid balance
Secondary study objectives
Adverse Events
Blood pressure
Heart rate
+13 moreTrial Design
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Electrolyte solution without glycerol beverage 3Experimental Treatment1 Intervention
Higher electrolytes higher volume
Group II: Electrolyte solution without glycerol beverage 2Experimental Treatment1 Intervention
Lower electrolytes mid-volume
Group III: Electrolyte solution without glycerol beverage 1Experimental Treatment1 Intervention
Higher electrolytes lower volume
Group IV: Electrolyte solution with glycerol beverage 3Experimental Treatment1 Intervention
Higher electrolytes, higher glycerol, higher volume
Group V: Electrolyte solution with glycerol beverage 2Experimental Treatment1 Intervention
Higher electrolytes, higher glycerol, lower volume
Group VI: Electrolyte solution with glycerol beverage 1Experimental Treatment1 Intervention
Lower electrolytes, lower glycerol, lower volume
Group VII: Base with glycerol beverage 3Experimental Treatment1 Intervention
No electrolytes, higher glycerol, higher volume
Group VIII: Base with glycerol beverage 2Experimental Treatment1 Intervention
No electrolytes, lower glycerol, mid-volume
Group IX: Base with glycerol beverage 1Experimental Treatment1 Intervention
No electrolytes, higher glycerol, lower volume
Group X: Placebo beveragePlacebo Group1 Intervention
Base beverage, no electrolytes, no glycerol
Find a Location
Closest Location:GCP Research· Saint Petersburg, FL
Who is running the clinical trial?
PepsiCo Global R&DLead Sponsor
98 Previous Clinical Trials
13,480 Total Patients Enrolled
1 Trials studying Fluid Balance
95 Patients Enrolled for Fluid Balance
Lawrence Galitz, MDPrincipal InvestigatorGCP Research
2 Previous Clinical Trials
50 Total Patients Enrolled