Clinical Trial

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

Recruiting
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Record status
This record was last updated February 11, 2025 (before its estimated May 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-21; most recent amendment 2025-02-07.
Trial Details
NCT Number NCT06654557
Lead Sponsor PepsiCo Global R&D
Conditions Fluid Balance
Enrollment 95 participants
Start Date 2024-09-30
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-11