Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
NCT ID: NCT06854471
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-04-09
2025-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Placebo beverage
Base beverage, no electrolytes, no glycerol
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
Electrolyte solution without glycerol beverage 1
Higher electrolytes lower volume
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.
Electrolyte solution without glycerol beverage 2
Lower electrolytes mid-volume
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.
Electrolyte solution without glycerol beverage 3
Higher electrolytes higher volume
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.
Electrolyte solution with glycerol beverage 1
Lower electrolytes, lower glycerol, lower volume
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.
Electrolyte solution with glycerol beverage 2
Higher electrolytes, higher glycerol, lower volume
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.
Electrolyte solution with glycerol beverage 3
Higher electrolytes, higher glycerol, higher volume
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.
Base with glycerol beverage 1
No electrolytes, higher glycerol, lower volume
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.
Base with glycerol beverage 2
No electrolytes, lower glycerol, mid-volume
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.
Base with glycerol beverage 3
No electrolytes, higher glycerol, higher volume
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.
Interventions
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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.
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.
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.
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.
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.
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
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
ALL
Yes
Sponsors
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PepsiCo Global R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsay Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
PepsiCo R&D/Gatorade and Sports Science Institute
Locations
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IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
Bradenton, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Gatorade Sports Science Institute
Valhalla, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Lindsay Baker, PhD
Role: primary
Other Identifiers
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PEP-2420
Identifier Type: -
Identifier Source: org_study_id
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