Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

ConditionFluid Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPepsiCo Global R&D

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)

    Other intervention

    9.3 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 intervention

    9.3 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 intervention

    9.3 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 intervention

    9.3 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 intervention

    9.3 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 intervention

    9.3 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 intervention

    9.3 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

95 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Placebo beverage (Parts 1 and 2)Placebo comparator 1 intervention
Group B: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)Experimental treatment 1 intervention
Group C: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)Experimental treatment 1 intervention
Group D: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Experimental treatment 1 intervention
Group E: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Experimental treatment 1 intervention
Group F: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Experimental treatment 1 intervention
Group G: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fluid balance (Body Weight)

Platform scale to the nearest 0.005 kilograms (kg)

Time frame
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
2

Fluid balance (Percent (%) change in Body Mass)

Platform scale to the nearest 0.005 kilograms (kg)

Time frame
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

Secondary outcomes

1

Fluid retention

Platform scale to the nearest 0.005 kilograms (kg), unit percent (%)

Time frame
% change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
2

Urine mass

Graduated cylinder on scale to the nearest 0.01 grams

Time frame
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
3

Urine specific gravity

USG digital pen refractometer (Atago), no unit

Time frame
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
4

Blood sodium

Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)

Time frame
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

Other outcomes

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