Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Status
Enrolling
Conditions
Fluid Balance
Treatments
Other: Electrolyte solution with glycerol beverage 2
Other: Base with glycerol, no electrolytes beverage 1
Other: Base with glycerol, no electrolytes beverage 3
Other: Electrolyte solution with glycerol beverage 1
Other: Base with glycerol, no electrolytes beverage 2
Other: Electrolyte solution with glycerol beverage 3
Other: Electrolyte solution without glycerol beverage 3
Other: Placebo beverage, kiwi-strawberry flavor
Other: Electrolyte solution without glycerol beverage 2
Other: Electrolyte solution without glycerol beverage 1
Details and patient eligibility
About
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.
Enrollment
80 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)
- 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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
80 participants in 10 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
Electrolyte solution without glycerol beverage 1
Experimental group
Description:
Higher electrolytes lower volume
Treatment:
Other: Electrolyte solution without glycerol beverage 1
Electrolyte solution without glycerol beverage 2
Experimental group
Description:
Lower electrolytes mid-volume
Treatment:
Other: Electrolyte solution without glycerol beverage 2
Electrolyte solution without glycerol beverage 3
Experimental group
Description:
Higher electrolytes higher volume
Treatment:
Other: Electrolyte solution without glycerol beverage 3
Electrolyte solution with glycerol beverage 1
Experimental group
Description:
Lower electrolytes, lower glycerol, lower volume
Treatment:
Other: Electrolyte solution with glycerol beverage 1
Electrolyte solution with glycerol beverage 2
Experimental group
Description:
Higher electrolytes, higher glycerol, lower volume
Treatment:
Other: Electrolyte solution with glycerol beverage 2
Electrolyte solution with glycerol beverage 3
Experimental group
Description:
Higher electrolytes, higher glycerol, higher volume
Treatment:
Other: Electrolyte solution with glycerol beverage 3
Base with glycerol beverage 1
Experimental group
Description:
No electrolytes, higher glycerol, lower volume
Treatment:
Other: Base with glycerol, no electrolytes beverage 1
Base with glycerol beverage 2
Experimental group
Description:
No electrolytes, lower glycerol, mid-volume
Treatment:
Other: Base with glycerol, no electrolytes beverage 2
Base with glycerol beverage 3
Experimental group
Description:
No electrolytes, higher glycerol, higher volume
Treatment:
Other: Base with glycerol, no electrolytes beverage 3
Trial contacts and locations
3
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Central trial contact
Lindsay Baker, PhD
Data sourced from clinicaltrials.gov
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