Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women

PepsiCo

Status: Enrolling

Conditions: Fluid Balance

Treatments: Other: Experimental glycerol beverage, kiwi-strawberry flavor; Other: Placebo beverage, kiwi-strawberry flavor

Study type: Interventional

Funder types: Industry

Identifiers

NCT07217834

PEP-2511

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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, laxatives, weight loss drugs)
• Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
• Subject is not allergic to fuji apple pear flavoring
• Subject is not allergic to Stevia
• Subject is willing to avoid alcohol consumption 24 hours prior to visits
• Subject is willing to fast overnight (~8-10 hours) prior to visits
• 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 study session.
• Willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits.

Exclusion criteria

• 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

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo Beverage

Placebo Comparator group

Description:

Base beverage, no electrolytes, no glycerol

Treatment:

Other: Placebo beverage, kiwi-strawberry flavor

Experimental Beverage

Experimental group

Description:

Glycerol beverage with electrolytes

Treatment:

Other: Experimental glycerol beverage, kiwi-strawberry flavor