Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration 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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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 2

    Other intervention

    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, no electrolytes beverage 3

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Placebo beveragePlacebo comparator 1 intervention
Group B: Electrolyte solution without glycerol beverage 1Experimental treatment 1 intervention
Group C: Electrolyte solution without glycerol beverage 2Experimental treatment 1 intervention
Group D: Electrolyte solution without glycerol beverage 3Experimental treatment 1 intervention
Group E: Electrolyte solution with glycerol beverage 1Experimental treatment 1 intervention
Group F: Electrolyte solution with glycerol beverage 2Experimental treatment 1 intervention
Group G: Electrolyte solution with glycerol beverage 3Experimental treatment 1 intervention
Group H: Base with glycerol beverage 1Experimental treatment 1 intervention
Group I: Base with glycerol beverage 2Experimental treatment 1 intervention
Group J: Base with glycerol beverage 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fluid balance

Calculated as change in body mass kg and %

Time frame
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes

Secondary outcomes

1

Urine mass

(g)

Time frame
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
2

Urine specific gravity

(au)

Time frame
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
3

Urine osmolality

(mosmol/kg)

Time frame
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
4

Whole blood hematocrit

(%)

Time frame
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes

Other outcomes

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