Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
NCT06654557 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2025-02-11
Summary
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.
Conditions
- Fluid Balance
Interventions
- OTHER
-
Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)
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.
- OTHER
-
0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)
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.
- OTHER
-
0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)
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.
- OTHER
-
1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
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.
- OTHER
-
6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
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.
- OTHER
-
6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
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.
- OTHER
-
2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
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.
Sponsors & Collaborators
-
PepsiCo Global R&D
lead INDUSTRY
Principal Investigators
-
Lindsay Baker, PhD · PepsiCo R&D Life Sciences, Sports Science
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2025-05-30
- Completion
- 2025-05-30
Countries
- United States
Study Locations
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