Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
ConditionFluid Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPepsiCo Global R&D
About this trial
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is male or female
If female, subject is not pregnant
Subject is 18-50 years of age, inclusive
Subject is at least recreationally active (engaged in light to moderate intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
Disqualifiers
Subject has participated in a clinical trial within the past 30 days
Subject has participated in any PepsiCo trial within past 3 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 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.
Trial design
Design model
Crossover
Treatments tested in this trial
Placebo beverage, kiwi-strawberry flavor
Other intervention3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.
Experimental glycerol beverage, kiwi-strawberry flavor
Other intervention3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Placebo BeveragePlacebo comparator 1 intervention
Group B: Experimental BeverageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fluid balance
Calculated as change in nude body mass, %
Time frame
Through study completion, average of 3 weeksSecondary outcomes
1
Fluid Balance
Calculated as change in nude body mass, kg
Time frame
Through study completion, average of 3 weeks2
Urine Mass
(g)
Time frame
Through study completion, average of 3 weeks3
Beverage Hydration Index
calculated as the cumulative urine mass after drinking the placebo divided by the cumulative urine mass after drinking the test beverage
Time frame
Through study completion, average of 3 weeks4
Urine specific gravity
(au)
Time frame
Through study completion, average of 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov