About this trial
The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.
In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
If female, subject is not pregnant (based on self-report)
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)
Disqualifiers
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
Crossover
Treatments tested in this trial
Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.
0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
Other intervention9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Treatment groups
7
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Fluid balance (Body Weight)
Platform scale to the nearest 0.005 kilograms (kg)
Fluid balance (Percent (%) change in Body Mass)
Platform scale to the nearest 0.005 kilograms (kg)
Secondary outcomes
Fluid retention
Platform scale to the nearest 0.005 kilograms (kg), unit percent (%)
Urine mass
Graduated cylinder on scale to the nearest 0.01 grams
Urine specific gravity
USG digital pen refractometer (Atago), no unit
Blood sodium
Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)
Sponsors and contacts
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