Hydration Dynamics and Influence of Beverage Composition

Dehydration Clinical Trial

Official title:

Hydration Dynamics and Influence of Beverage Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111392
• Other study ID #: 2021-0823
• Secondary ID: Abbott Nutrition
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 3, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Fluid Retention
• Hydration

Intervention

Biological:
• Placebo
Ingestion of one (1) liter of beverage with observation for 2 h
• Oral Rehydration Solution 1
Ingestion of one (1) liter of beverage with observation for 2 h
• Oral Rehydration Solution 2
Ingestion of one (1) liter of beverage with observation for 2 h

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of appearance of deuterium in the plasma for placebo	Measure 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.	2 hours
Primary	Rate of appearance of deuterium in the plasma for oral rehydration solution 1.	Measure 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.	2 hours
Primary	Rate of appearance of deuterium in the plasma for oral rehydration solution 2.	Measure 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.	2 hours
Secondary	Fluid retention for placebo	Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.	2 hours
Secondary	Fluid retention for oral rehydration solution 1	Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.	2 hours
Secondary	Fluid retention for oral rehydration solution 2	Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.	2 hours
Secondary	Change in plasma volume for placebo	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours
Secondary	Change in plasma volume for oral rehydration solution 1	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours
Secondary	Change in plasma volume for oral rehydration solution 2	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours