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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654557 on ClinicalTrials.gov