Clinical trial NCT06854471: Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Official title: Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fluid Balance
Keywords: hydration
electrolytes
glycerol
beverage
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.

The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.


Eligibility criteria: Inclusion Criteria:

* 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)
* Subject does not smoke (or has quit for at least 6 months)
* Subject is not taking medication that may interfere with the study (e.g., diuretics)
* Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
* Subject is willing to fast overnight (\~8-12 hours)
* Subject is willing to refrain from vigorous exercise for 24 hours
* Subject is willing to eat the exact same food the day prior to each visit to the laboratory
* Provision of written consent to participate

Exclusion Criteria:

* Subject has participated in a clinical trial within the past 30 days
* Subject has participated in any PepsiCo trial within past 6 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.

Primary outcomes:
measure: Fluid balance
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Secondary outcomes:
measure: Urine mass
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Urine specific gravity
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Urine osmolality
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Whole blood hematocrit
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Whole blood hemoglobin concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum sodium concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum potassium concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum chloride concentration (mmol/L)
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum glucose concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum glycerol concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum copeptin concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Serum osmolality
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
measure: Blood pressure
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Heart rate
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Subjective measures of gastrointestinal discomfort and headache (VAS)
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
measure: Menstrual categorization
timeFrame: Screening visit
measure: Adverse Events
timeFrame: From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
Study officials:
affiliation: GCP Research
name: Lawrence Galitz, MD
role: PRINCIPAL_INVESTIGATOR
References: