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Recruiting NCT06854471

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

No phase Interventional Fluid Balance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo beverage, kiwi-strawberry flavor, Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2, Electrolyte solution without glycerol beverage 3.
Who it may be relevant to
Registry conditions: Fluid Balance. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Fluid balance [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
Secondary outcome measures (12)
  • Urine mass [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
  • Urine specific gravity [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
  • Urine osmolality [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
  • Whole blood hematocrit [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Whole blood hemoglobin concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum sodium concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum potassium concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum chloride concentration (mmol/L) [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum glucose concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum glycerol concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum copeptin concentration [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
  • Serum osmolality [Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 3 centers
  • IMG Academy/GSSI Bradenton Gatorade Sports Science Institute — Bradenton
  • GCP Research — St. Petersburg
  • Gatorade Sports Science Institute — Valhalla

Identifiers

NCT: NCT06854471 · PEP-2420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗