RecruitingNot ApplicableNCT06854471

Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Sponsor

PepsiCo Global R&D

Enrollment

80 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Fluid Balance

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria12

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 Criteria4

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.

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Interventions

OTHERPlacebo beverage, kiwi-strawberry flavor

9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose

OTHERElectrolyte solution without glycerol beverage 1

4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERElectrolyte solution without glycerol beverage 2

6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERElectrolyte solution without glycerol beverage 3

9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERElectrolyte solution with glycerol beverage 1

4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERElectrolyte solution with glycerol beverage 2

4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERElectrolyte solution with glycerol beverage 3

9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERBase with glycerol, no electrolytes beverage 1

4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERBase with glycerol, no electrolytes beverage 2

6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

OTHERBase with glycerol, no electrolytes beverage 3

9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.