Clinical trial NCT06185595: Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Official title: Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Keywords: hydration
euhydration
fluid balance
fluid retention
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2023-12-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.


Eligibility criteria: Inclusion Criteria:

* Subject is male or female
* If female, subject is not pregnant
* Subject is 18-50 years of age, inclusive
* You are 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 as indicated on the general health questionnaire (GHQ), 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
* Able to speak, write, and read English
* 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 0, 30, 60, 90,120 and 180 minutes
Secondary outcomes:
measure: Fluid retention
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
measure: Urine mass
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
measure: Urine specific gravity
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
measure: Blood sodium
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
measure: Blood glucose
timeFrame: Screening visit only
measure: Blood glucose
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
measure: Percent change in plasma volume
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
measure: Serum glycerol concentration
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
measure: Blood pressure
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
measure: Heart rate
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
measure: Subjective measures of gastrointestinal discomfort and headache
timeFrame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
measure: Menstrual cycle phase
timeFrame: Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: PepsiCo R&D, Gatorade Sports Science Institute
state: New York
Study officials:
affiliation: PepsiCo, Inc. Sports Science
name: Lindsay Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: