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Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids

Sponsor
Loughborough University (Other)
Overall Status
Completed
CT.gov ID
NCT05698849
Collaborator
Entrinsic Beverage Company LLC (Other)
15
Enrollment
1
Location
3
Arms
11.2
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effects of a moderate amount 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Composition of Sports Drink
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Double-blind, randomised, crossover designDouble-blind, randomised, crossover design
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Basic Science
Official Title:
Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Jan 27, 2022
Actual Study Completion Date :
Jul 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Commercially Available Sports Drink A

A commercially available flavored electrolyte solution, The Coca-Cola Company

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 flavored carbohydrate-electrolyte solution, PepsiCo

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 flavored electrolyte solution, The Coca-Cola Company), but with the addition of a small amount of amino acids.

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.

Outcome Measures

Primary Outcome Measures

  1. Time at which drink absorption rate was maximum (tmax) [60 minutes]

    Determined from D2O values in venous blood samples collected before and after drink ingestion

  2. Maximum absorption of drink (Cmax) [60 minutes]

    Determined from D2O values in venous blood samples collected before and after drink ingestion

  3. Area under the curve for D2O [60 minutes]

    Determined from D2O values in venous blood samples collected before and after drink ingestion

Secondary Outcome Measures

  1. Plasma volume [60 minutes]

    Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion

  2. Plasma osmolality [60 minutes]

    Determined from venous blood samples collected before and after drink ingestion

  3. Urine specific gravity [60 minutes]

    Determined from urine samples collected before and after drink ingestion

  4. Urine volume [Post-trial (at 60 minutes)]

    Determined from urine samples collected after drink ingestion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loughborough University Loughborough Leicestershire United Kingdom LE11 3TU

Sponsors and Collaborators

  • Loughborough University
  • Entrinsic Beverage Company LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lewis James, Senior Lecturer in Nutrition, Loughborough University
ClinicalTrials.gov Identifier:
NCT05698849
Other Study ID Numbers:
  • LEON3151-2859
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 26, 2023