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

Purpose

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.

Condition

  • Fluid Balance

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo beverage 		Base beverage, no electrolytes, no glycerol
  • Other: Placebo 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
Experimental
Electrolyte solution without glycerol beverage 1 		Higher electrolytes lower volume
  • Other: Electrolyte 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.
Experimental
Electrolyte solution without glycerol beverage 2 		Lower electrolytes mid-volume
  • Other: Electrolyte 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.
Experimental
Electrolyte solution without glycerol beverage 3 		Higher electrolytes higher volume
  • Other: Electrolyte 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.
Experimental
Electrolyte solution with glycerol beverage 1 		Lower electrolytes, lower glycerol, lower volume
  • Other: Electrolyte 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.
Experimental
Electrolyte solution with glycerol beverage 2 		Higher electrolytes, higher glycerol, lower volume
  • Other: Electrolyte 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.
Experimental
Electrolyte solution with glycerol beverage 3 		Higher electrolytes, higher glycerol, higher volume
  • Other: Electrolyte 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.
Experimental
Base with glycerol beverage 1 		No electrolytes, higher glycerol, lower volume
  • Other: Base 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.
Experimental
Base with glycerol beverage 2 		No electrolytes, lower glycerol, mid-volume
  • Other: Base 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.
Experimental
Base with glycerol beverage 3 		No electrolytes, higher glycerol, higher volume
  • Other: Base 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.

Recruiting Locations

GCP Research
Saint Petersburg, Florida 33705
Contact:
Jessica Cruz, RN
727-520-1427
jcruz@researchgcp.com

More Details

NCT ID
NCT06854471
Status
Recruiting
Sponsor
PepsiCo Global R&D

Study Contact

Lindsay Baker, PhD
800.884.2867
Lindsay.Baker@pepsico.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center