Clinical Trials Directory

Trials / Completed

CompletedNCT05111392

Hydration Dynamics and Influence of Beverage Composition

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
14 (actual)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.

Detailed description

Using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. Comparisons will be made between beverages for indices of the rate of appearance of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster absorption (D2O appearance rate), and better overall hydration (expanded PV and higher modified BHI) will occur for beverages containing glucose and sodium compared to water. Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlaceboIngestion of one (1) liter of beverage with observation for 2 h
BIOLOGICALOral Rehydration Solution 1Ingestion of one (1) liter of beverage with observation for 2 h
BIOLOGICALOral Rehydration Solution 2Ingestion of one (1) liter of beverage with observation for 2 h

Timeline

Start date
2021-09-03
Primary completion
2022-10-31
Completion
2022-11-30
First posted
2021-11-08
Last updated
2023-07-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05111392. Inclusion in this directory is not an endorsement.