Hydration Dynamics and Influence of Beverage Composition

NCT05111392 | Completed Phase 1

• 2 other identifiers: 2021-0823Abbott Nutrition (EAS)
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration; Fluid Retention; Dehydration

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Fluid retention for placebo

  2 hours

• Fluid retention for oral rehydration solution 1

  2 hours

• Fluid retention for oral rehydration solution 2

  2 hours

• Change in plasma volume for placebo

  2 hours

• Change in plasma volume for oral rehydration solution 1

  2 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Water

Biological: Placebo

Oral rehydration solution 1

EXPERIMENTAL

Beverage with 2.5% glucose with 45 mmol sodium/L.

Biological: Oral Rehydration Solution 1

Oral rehydration solution 2

EXPERIMENTAL

Beverage with 1.7% glucose with 60 mmol sodium/L.

Biological: Oral Rehydration Solution 2

Interventions

Placebo BIOLOGICAL

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

Placebo

Oral Rehydration Solution 1 BIOLOGICAL

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

Oral rehydration solution 1

Oral Rehydration Solution 2 BIOLOGICAL

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

Oral rehydration solution 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig A Horswill, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Beverages will have similar color, flavoring, and taste.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Mixed model.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 8, 2021
• Study Start: September 3, 2021
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)