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Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
NCT06654557 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)
- OTHER 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)
- OTHER 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)
- OTHER 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- OTHER 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
Study Locations (1)
New York
- PepsiCo R&D, Gatorade Sports Science Institute — Valhalla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2025-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06654557
The ClinicalTrials.gov registry entry for NCT06654557 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PepsiCo Global R&D, which has 76 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fluid Balance appearing as the primary indexed condition, and to 5 interventions — of which Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06654557 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06654557 about?
NCT06654557 is a clinical study titled "Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest". 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 inte...
What is the current status of trial NCT06654557?
This trial is currently recruiting. It is a NA study. The enrollment target is 95 participants. The study started on 2024-09-30. Estimated completion is 2025-05-30.
What conditions does trial NCT06654557 study?
This clinical trial studies the following conditions: Fluid Balance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06654557?
The interventions under investigation include: Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2) (OTHER), 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) (OTHER), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) (OTHER), 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) (OTHER), 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06654557?
This trial is sponsored by PepsiCo Global R&D, which has 76 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06654557 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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