Hydration Dynamics and Influence of Beverage Composition
Primary Purpose
Hydration, Fluid Retention, Dehydration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Oral Rehydration Solution 1
Oral Rehydration Solution 2
Sponsored by
About this trial
This is an interventional prevention trial for Hydration focused on measuring Hydration, Deuterium oxide, Plasma osmolality, Sodium, Urine production, Fluid absorption, Euhydration
Eligibility Criteria
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.
Sites / Locations
- University of Illinois Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Oral rehydration solution 1
Oral rehydration solution 2
Arm Description
Water
Beverage with 2.5% glucose with 45 mmol sodium/L.
Beverage with 1.7% glucose with 60 mmol sodium/L.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Fluid retention for placebo
Measure 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 1
Measure 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 2
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Change in plasma volume for placebo
Increase in plasma volume (water content of the blood) following ingestion of beverage
Change in plasma volume for oral rehydration solution 1
Increase in plasma volume (water content of the blood) following ingestion of beverage
Change in plasma volume for oral rehydration solution 2
Increase in plasma volume (water content of the blood) following ingestion of beverage
Full Information
NCT ID
NCT05111392
First Posted
November 4, 2021
Last Updated
July 13, 2023
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05111392
Brief Title
Hydration Dynamics and Influence of Beverage Composition
Official Title
Hydration Dynamics and Influence of Beverage Composition
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydration, Fluid Retention, Dehydration
Keywords
Hydration, Deuterium oxide, Plasma osmolality, Sodium, Urine production, Fluid absorption, Euhydration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Mixed model.
Masking
Participant
Masking Description
Beverages will have similar color, flavoring, and taste.
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water
Arm Title
Oral rehydration solution 1
Arm Type
Experimental
Arm Description
Beverage with 2.5% glucose with 45 mmol sodium/L.
Arm Title
Oral rehydration solution 2
Arm Type
Experimental
Arm Description
Beverage with 1.7% glucose with 60 mmol sodium/L.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Ingestion of one (1) liter of beverage with observation for 2 h
Intervention Type
Biological
Intervention Name(s)
Oral Rehydration Solution 1
Intervention Description
Ingestion of one (1) liter of beverage with observation for 2 h
Intervention Type
Biological
Intervention Name(s)
Oral Rehydration Solution 2
Intervention Description
Ingestion of one (1) liter of beverage with observation for 2 h
Primary Outcome Measure Information:
Title
Rate of appearance of deuterium in the plasma for placebo
Description
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.
Time Frame
2 hours
Title
Rate of appearance of deuterium in the plasma for oral rehydration solution 1.
Description
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.
Time Frame
2 hours
Title
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Fluid retention for placebo
Description
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Time Frame
2 hours
Title
Fluid retention for oral rehydration solution 1
Description
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Time Frame
2 hours
Title
Fluid retention for oral rehydration solution 2
Description
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Time Frame
2 hours
Title
Change in plasma volume for placebo
Description
Increase in plasma volume (water content of the blood) following ingestion of beverage
Time Frame
2 hours
Title
Change in plasma volume for oral rehydration solution 1
Description
Increase in plasma volume (water content of the blood) following ingestion of beverage
Time Frame
2 hours
Title
Change in plasma volume for oral rehydration solution 2
Description
Increase in plasma volume (water content of the blood) following ingestion of beverage
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig A Horswill, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
If shared, the main outcome variables will be posted.
Learn more about this trial
Hydration Dynamics and Influence of Beverage Composition
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