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A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration

Primary Purpose

Fluid Balance Outcomes

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Composition of oral rehydration solutions
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fluid Balance Outcomes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-45 years of age male or female good health Exclusion Criteria: Gastrointestinal, cardiovascular or renal conditions; other health conditions that might influence the study outcomes. Medication use (e.g. anti-biotics, diuretics, NSAIDS etc.) that might influence the study outcomes or interact with furosemide. Allergy to sulfonamides (sulfa drugs). Smoking (including vaping) Amenorrhoeic females Any high-level/elite athlete, or aspiring high level athlete, where drug testing/regulations are carried out and regulations need to be followed (furosemide is prohibited in sport as it is used as a masking agent).

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Commercially Available Oral Rehydration Solution A

Commercially Available Oral Rehydration Solution B

Commercially Available Oral Rehydration Solution C

Arm Description

A commercially available oral rehydration solution (~2.8% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium, 34 mmol/L chloride)

A commercially available oral rehydration solution (~0.1% carbohydrate, ~2% amino acids (protein), ~67 mmol/L sodium, ~20 mmol/L potassium, 30 mmol/L chloride)

A commercially available oral rehydration solution (~2.2% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium)

Outcomes

Primary Outcome Measures

Net fluid balance
Determined from urine output and drink volume collected before and after drink ingestion
Drink retention
Determined from urine output and drink volume collected before and after drink ingestion
Electrolyte balance
Determined from electrolyte concentrations (i.e., sodium, potassium, chloride) in urine and drink samples before and after drink ingestion
Speed of rehydration
Determined from urine output and drink volume collected before and after drink ingestion

Secondary Outcome Measures

Plasma volume
Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion
Plasma osmolality
Determined from venous blood samples collected before and after drink ingestion
Urine volume
Determined from urine samples collected before and after drink ingestion
Urine electrolyte concentration (i.e., sodium, potassium, chloride)
Determined from urine samples collected before and after drink ingestion
Blood electrolyte concentration (i.e., sodium, potassium, chloride)
Determined from blood samples collected before and after drink ingestion
Body mass change
Determined from weighing participants before and after drink ingestion
Urine specific gravity
Determined from urine samples collected before and after drink ingestion

Full Information

First Posted
March 7, 2023
Last Updated
August 14, 2023
Sponsor
Loughborough University
Collaborators
entrinsic bioscience LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05775055
Brief Title
A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration
Official Title
A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
October 3, 2023 (Anticipated)
Study Completion Date
October 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
entrinsic bioscience LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Dehydration is commonplace in a number of settings, including exercise, daily living (i.e. inadequate fluid intake) and with relatively common bacterial/viral infections that induce diarrhoea and/or vomiting. As such, it is important to develop effective strategies to facilitate the recovery and maintenance of body water (i.e. rehydration). Whilst rehydration from exercise dehydration has been well-studied, rehydration from other types of dehydration have not. Despite this, oral rehydration solutions have been produced and are commercially available (in chemists/pharmacies and supermarkets) to help recover from dehydration produced by illnesses like diarrhoea and vomiting. Most commercially available oral rehydration solutions use a sugar-base (glucose) and a mixture of electrolytes, but little work has gone into evaluating the efficacy of such solutions. Furthermore, more recent work has explored the use of proteins that they may offer some advantage over sugar/glucose-based beverages. Therefore, the aim of this study is to investigate the efficacy of a protein-based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions.
Detailed Description
Dehydration refers to a decrease in body water and occurs when water losses in urine, sweat or other body fluid secretions (e.g vomit or diarrhoea) exceed fluid intake in drinks and foods. Indeed, dehydration is commonplace in a number of settings, including exercise, daily living (i.e. inadequate fluid intake) and with relatively common bacterial/viral infections that induce diarrhoea and/or vomiting. As such it is important to develop effective strategies to facilitate the recovery and maintenance of body water (i.e. rehydration). Whilst rehydration from exercise dehydration has been well-studied, rehydration from other types of dehydration have not. Despite this, oral rehydration solutions have been produced and are commercially available (in chemists/pharmacies and supermarkets) to help recover from dehydration produced by illnesses like diarrhoea and vomiting. Oral rehydration solutions have been developed that vary in their composition for both electrolytes and other nutrients (glucose, amino acids etc.). Most commercially available oral rehydration solutions use a sugar-base (glucose) and a mixture of electrolytes, but little work has gone into evaluating the efficacy of such solutions. Furthermore, more recent work has explored the use of amino acids (the building blocks of proteins) in isolation or as complete proteins and suggest that they may offer some advantage over sugar/glucose-based beverages. Dehydration produced by illnesses like diarrhoea and vomiting cause water an electrolyte losses that are different in nature to exercise and as such, exercise is not a good way to study these effects. The type of dehydration produced with diarrhoea and vomiting can be mimicked by using a diuretic like furosemide. This type of diuretic is used clinically in situations of water overload (e.g. congestive heart failure or high blood pressure) and are used daily for months in many patients. They produce mild dehydration (~2-2.5%) and thus offer the opportunity to understand recovery from the type of dehydration caused by illness, without the presence of illness. Given the body water contains high amounts of salts (electrolyte), when dehydration occurs electrolytes are also lost from the body. These electrolytes are needed to retain water in the various spaces of the body (inside cells, in the blood etc.) and thus failure to replace the electrolytes lost during dehydration will lead to a less effective rehydration response. Therefore, commercial oral rehydration solutions contain a balance of different electrolytes to replace those lost with dehydration and to help retain the ingested fluid. However, different formulations use a different balance of electrolytes and little work has examined the efficacy of these different formulations. Therefore there is a need to understand the efficacy of different oral rehydration solution formulations following dehydration, something that has received little attention to date, surprisingly. Therefore, this study will compare the rehydration efficacy of a commercial amino-acid based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions after dehydration induced by a diuretic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Balance Outcomes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, randomised, crossover design
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Commercially Available Oral Rehydration Solution A
Arm Type
Experimental
Arm Description
A commercially available oral rehydration solution (~2.8% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium, 34 mmol/L chloride)
Arm Title
Commercially Available Oral Rehydration Solution B
Arm Type
Experimental
Arm Description
A commercially available oral rehydration solution (~0.1% carbohydrate, ~2% amino acids (protein), ~67 mmol/L sodium, ~20 mmol/L potassium, 30 mmol/L chloride)
Arm Title
Commercially Available Oral Rehydration Solution C
Arm Type
Experimental
Arm Description
A commercially available oral rehydration solution (~2.2% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium)
Intervention Type
Other
Intervention Name(s)
Composition of oral rehydration solutions
Intervention Description
Investigate the efficacy of an amino acid-based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions.
Primary Outcome Measure Information:
Title
Net fluid balance
Description
Determined from urine output and drink volume collected before and after drink ingestion
Time Frame
9 hours
Title
Drink retention
Description
Determined from urine output and drink volume collected before and after drink ingestion
Time Frame
4 hours
Title
Electrolyte balance
Description
Determined from electrolyte concentrations (i.e., sodium, potassium, chloride) in urine and drink samples before and after drink ingestion
Time Frame
9 hours
Title
Speed of rehydration
Description
Determined from urine output and drink volume collected before and after drink ingestion
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Plasma volume
Description
Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion
Time Frame
9 hours
Title
Plasma osmolality
Description
Determined from venous blood samples collected before and after drink ingestion
Time Frame
9 hours
Title
Urine volume
Description
Determined from urine samples collected before and after drink ingestion
Time Frame
9 hours
Title
Urine electrolyte concentration (i.e., sodium, potassium, chloride)
Description
Determined from urine samples collected before and after drink ingestion
Time Frame
9 hours
Title
Blood electrolyte concentration (i.e., sodium, potassium, chloride)
Description
Determined from blood samples collected before and after drink ingestion
Time Frame
9 hours
Title
Body mass change
Description
Determined from weighing participants before and after drink ingestion
Time Frame
9 hours
Title
Urine specific gravity
Description
Determined from urine samples collected before and after drink ingestion
Time Frame
9 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: 18-45 years of age male or female good health Exclusion Criteria: Gastrointestinal, cardiovascular or renal conditions; other health conditions that might influence the study outcomes. Medication use (e.g. anti-biotics, diuretics, NSAIDS etc.) that might influence the study outcomes or interact with furosemide. Allergy to sulfonamides (sulfa drugs). Smoking (including vaping) Amenorrhoeic females Any high-level/elite athlete, or aspiring high level athlete, where drug testing/regulations are carried out and regulations need to be followed (furosemide is prohibited in sport as it is used as a masking agent).
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

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A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration

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