Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids

February 12, 2021 updated by: Lewis James, Loughborough University
To determine the effects of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes and in urine (60 min). Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Loughborough, Leicestershire, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Generally fit and healthy (determined by health screen questionnaire)
  • Recreationally active (minimum 3 hours of physical activity per week including walking)

Exclusion Criteria:

  • Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes
  • Smoking (including vaping)
  • BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Commercially Available Sports Drink A
A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes
Other: Composition of Sports Drink
The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
Experimental: Commercially Available Sports Drink B
A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes.
Other: Composition of Sports Drink
The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
Experimental: Commercially Available Sports Drink A with added Amino Acids
The same as sports drink A above (a commercially available sports water, with small amounts of flavouring, sweetener and electrolytes), but with the addition of a small amount of amino acids (~0.7 g/100 ml).
Other: Composition of Sports Drink
The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time at which drink absorption rate was maximum (t1)
Time Frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
60 minutes
Time at which drink absorption rate returned to 0 (t2)
Time Frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
60 minutes
Time at which 50% of drink was absorbed (t1/2)
Time Frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
60 minutes
Maximum absorption rate of drink
Time Frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
60 minutes
Area under the curve for D2O
Time Frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma volume
Time Frame: 60 minutes
Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion
60 minutes
Plasma osmolality
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Plasma glucose concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Plasma lactate concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Plasma creatinine concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Plasma amino acid concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Urinary specific gravity
Time Frame: 60 minutes
Determined from urine samples collected before and after drink ingestion
60 minutes
Plasma sodium concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Plasma potassium concentration
Time Frame: 60 minutes
Determined from venous blood samples collected before and after drink ingestion
60 minutes
Urinary D2O concentration
Time Frame: 60 minutes
Determined from urine samples collected before and after drink ingestion
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loughborough University

Collaborators

Entrinsic Beverage Company LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

October 14, 2020

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • LEON1416

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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