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

NCT05775055 | Completed

• 1 other identifier: LEON8472
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Balance Outcomes

Outcome Measures

Primary Outcomes (4)

• Net fluid balance

  Determined from urine output and drink volume collected before and after drink ingestion

  9 hours

• Drink retention

  Determined from urine output and drink volume collected before and after drink ingestion

  4 hours

• Electrolyte balance

  Determined from electrolyte concentrations (i.e., sodium, potassium, chloride) in urine and drink samples before and after drink ingestion

  9 hours

• Speed of rehydration

  Determined from urine output and drink volume collected before and after drink ingestion

  4 hours

Secondary Outcomes (7)

• Plasma volume

  9 hours

• Plasma osmolality

  9 hours

• Urine volume

  9 hours

• Urine electrolyte concentration (i.e., sodium, potassium, chloride)

  9 hours

• Blood electrolyte concentration (i.e., sodium, potassium, chloride)

  9 hours

Study Arms (3)

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)

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)

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)

Other: Composition of oral rehydration solutions

Interventions

Composition of oral rehydration solutions OTHER

Investigate the efficacy of an amino acid-based oral rehydration solution compared to two current commercially available glucose-based oral rehydration solutions.

Commercially Available Oral Rehydration Solution A; Commercially Available Oral Rehydration Solution B; Commercially Available Oral Rehydration Solution C

Eligibility Criteria

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

You may qualify if:

• years of age
• male or female
• good health

You may not qualify if:

• 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).

Sponsors & Collaborators

• Loughborough University: lead
• entrinsic bioscience LLC: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Nutrition

Model Details: Double-blind, randomised, crossover design

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 14, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)