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Hydration Dynamics and Influence of Beverage Composition

Hydration Dynamics and Influence of Beverage Composition

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05111392
Enrollment
14
Registered
2021-11-08
Start date
2021-09-03
Completion date
2022-11-30
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Fluid Retention, Hydration

Keywords

Hydration, Deuterium oxide, Plasma osmolality, Sodium, Urine production, Fluid absorption, Euhydration

Brief 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.

Interventions

BIOLOGICALPlacebo

Ingestion of one (1) liter of beverage with observation for 2 h

BIOLOGICALOral Rehydration Solution 1

Ingestion of one (1) liter of beverage with observation for 2 h

BIOLOGICALOral Rehydration Solution 2

Ingestion of one (1) liter of beverage with observation for 2 h

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Beverages will have similar color, flavoring, and taste.

Intervention model description

Mixed model.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Have a BMI of 18.5 to 29.9 kg/m2. * Be normotensive (\<120/80 mm Hg). * Must be able to speak and read English. * Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial. * Fast for at least 8 hours prior to and through the study trial. * Be able to abstain from alcohol for 48 h prior to each study. * Be able to abstain from caffeine for 24 h prior to each study. * If female, must have regular menstrual cycles, that are \> 27 days and \< 35 days in length.

Exclusion criteria

* Under 18 y of age or over 45 y of age. * Have a BMI \<18.5 or \>30. * Being pregnant. * Lactating. * Tobacco user. * Have hypotension or hypertension. * Have any type of kidney disease or dysfunction. * Have diabetes. * Have any type of cardiovascular disease. * Have been diagnosed with galactosemia. * Females with irregular menstrual cycles. * Females with polycystic ovary disease.

Design outcomes

Primary

MeasureTime frameDescription
Rate of appearance of deuterium in the plasma for placebo2 hoursMeasure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Rate of appearance of deuterium in the plasma for oral rehydration solution 1.2 hoursMeasure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.2 hoursMeasure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.

Secondary

MeasureTime frameDescription
Change in plasma volume for placebo2 hoursIncrease in plasma volume (water content of the blood) following ingestion of beverage
Fluid retention for placebo2 hoursMeasure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Change in plasma volume for oral rehydration solution 22 hoursIncrease in plasma volume (water content of the blood) following ingestion of beverage
Change in plasma volume for oral rehydration solution 12 hoursIncrease in plasma volume (water content of the blood) following ingestion of beverage
Fluid retention for oral rehydration solution 12 hoursMeasure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Fluid retention for oral rehydration solution 22 hoursMeasure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026