Hydration Dynamics and Influence of Beverage Composition

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Hydration; Fluid Retention
• Intervention / Treatment: Biological: Placebo; Biological: Oral Rehydration Solution 1; Biological: Oral Rehydration Solution 2

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Craig A Horswill, PhD; Phone Number: 312-996-5656; Email: horswill@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Water	Biological: Placebo; Ingestion of one (1) liter of beverage with observation for 2 h
Experimental: Oral rehydration solution 1; Beverage with 2.5% glucose with 45 mmol sodium/L.	Biological: Oral Rehydration Solution 1; Ingestion of one (1) liter of beverage with observation for 2 h
Experimental: Oral rehydration solution 2; Beverage with 1.7% glucose with 60 mmol sodium/L.	Biological: Oral Rehydration Solution 2; Ingestion of one (1) liter of beverage with observation for 2 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change in plasma volume for placebo	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours
Change in plasma volume for oral rehydration solution 1	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours
Change in plasma volume for oral rehydration solution 2	Increase in plasma volume (water content of the blood) following ingestion of beverage	2 hours

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Craig A Horswill, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hydration; Sodium; Deuterium oxide; Plasma osmolality; Urine production; Fluid absorption; Euhydration
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Pharmaceutical Solutions
• Other Study ID Numbers: 2021-0823; Abbott Nutrition (EAS) (Other Grant/Funding Number: Non-Federal Industry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If shared, the main outcome variables will be posted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No