Fluid Balance OutcomesNCT05775055
A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration
A study testing Composition of oral rehydration solutions in people with Fluid Balance Outcomes, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Balance Outcomes
- What is being tested?
- Composition of oral rehydration solutions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2023to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- male or female
- good health
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
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.
Read the 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.
- Conditions
- Fluid Balance Outcomes
- Being tested
- Composition of oral rehydration solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composition of oral rehydration solutionsOther
Investigate the efficacy of an amino acid-based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions.
| Study group | Role | What they receive |
|---|---|---|
| Commercially Available Oral Rehydration Solution A | Experimental | A commercially available oral rehydration solution (~2.8% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium, 34 mmol/L chloride) Receives: Other: Composition of oral rehydration solutions |
| Commercially Available Oral Rehydration Solution B | Experimental | 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) Receives: Other: Composition of oral rehydration solutions |
| Commercially Available Oral Rehydration Solution C | Experimental | A commercially available oral rehydration solution (~2.2% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium) Receives: Other: Composition of oral rehydration solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net fluid balance
Determined from urine output and drink volume collected before and after drink ingestion
Measured: 9 hours
Drink retention
Determined from urine output and drink volume collected before and after drink ingestion
Measured: 4 hours
Electrolyte balance
Determined from electrolyte concentrations (i.e., sodium, potassium, chloride) in urine and drink samples before and after drink ingestion
Measured: 9 hours
Speed of rehydration
Determined from urine output and drink volume collected before and after drink ingestion
Measured: 4 hours
Secondary outcomes (7)
Plasma volume
Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion
Measured: 9 hours
Plasma osmolality
Determined from venous blood samples collected before and after drink ingestion
Measured: 9 hours
Urine volume
Determined from urine samples collected before and after drink ingestion
Measured: 9 hours
Urine electrolyte concentration (i.e., sodium, potassium, chloride)
Determined from urine samples collected before and after drink ingestion
Measured: 9 hours
Blood electrolyte concentration (i.e., sodium, potassium, chloride)
Determined from blood samples collected before and after drink ingestion
Measured: 9 hours
Body mass change
Determined from weighing participants before and after drink ingestion
Measured: 9 hours
Urine specific gravity
Determined from urine samples collected before and after drink ingestion
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start14 Mar 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Balance OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomised, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- entrinsic bioscience LLC
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775055
- Sponsor's protocol ID
- LEON8472
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Commercial Oral Rehydration Solutions Consumed After Extra-cellular Dehydration
- ClinicalTrials.gov ID
- NCT05775055
- Acronym / sponsor ID
- LEON8472
- Conditions
- Fluid Balance Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- entrinsic bioscience LLC
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind, randomised, crossover design
| Arm | Type | Receives |
|---|---|---|
| Commercially Available Oral Rehydration Solution A | Experimental | Other: Composition of oral rehydration solutionsA commercially available oral rehydration solution (~2.8% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium, 34 mmol/L chloride) |
| Commercially Available Oral Rehydration Solution B | Experimental | Other: Composition of oral rehydration solutionsA commercially available oral rehydration solution (~0.1% carbohydrate, ~2% amino acids (protein), ~67 mmol/L sodium, ~20 mmol/L potassium, 30 mmol/L chloride) |
| Commercially Available Oral Rehydration Solution C | Experimental | Other: Composition of oral rehydration solutionsA commercially available oral rehydration solution (~2.2% carbohydrate, ~45 mmol/L sodium, ~20 mmol/L potassium) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years of age
- male or female
- good health
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composition of oral rehydration solutionsInvestigate the efficacy of an amino acid-based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions. | Other | Commercially Available Oral Rehydration Solution A, Commercially Available Oral Rehydration Solution B, Commercially Available Oral Rehydration Solution C |
Primary outcome
Net fluid balance
Time frame: 9 hours
Determined from urine output and drink volume collected before and after drink ingestion
Drink retention
Time frame: 4 hours
Determined from urine output and drink volume collected before and after drink ingestion
Electrolyte balance
Time frame: 9 hours
Determined from electrolyte concentrations (i.e., sodium, potassium, chloride) in urine and drink samples before and after drink ingestion
Speed of rehydration
Time frame: 4 hours
Determined from urine output and drink volume collected before and after drink ingestion
7 secondary outcomes
Plasma volume
Time frame: 9 hours
Plasma osmolality
Time frame: 9 hours
Urine volume
Time frame: 9 hours
Urine electrolyte concentration (i.e., sodium, potassium, chloride)
Time frame: 9 hours
Blood electrolyte concentration (i.e., sodium, potassium, chloride)
Time frame: 9 hours
Body mass change
Time frame: 9 hours
Urine specific gravity
Time frame: 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composition of oral rehydration solutions in people with Fluid Balance Outcomes, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net fluid balance (time frame: 9 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.