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

Conditions

• Fluid Balance

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 30, 2024

Status verified

Feb 2025

Primary completion

May 30, 2025

Completion

May 30, 2025

Study Design

Enrollment

95 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Placebo Comparator: Placebo beverage (Parts 1 and 2)
• Experimental: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)
• Experimental: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)
• Experimental: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
• Experimental: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
• Experimental: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
• Experimental: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Primary Outcome Measure

Fluid balance (Body Weight) [ 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 ]

Central Contacts

• Lindsay Baker, PhD
  814-883-9454
  [email protected]

Locations (1)

Find similar trials in Valhalla, NY

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