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

Sponsor
Loughborough University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04819334
Collaborator
Entrinsic Beverage Company LLC (Other)
15
1
3
19.6
0.8

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 600 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
Anticipated 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 :
Feb 12, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 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 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

he 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 (~2.6 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.

Outcome Measures

Primary Outcome Measures

  1. Time at which drink absorption rate was maximum (t1) [60 minutes]

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

  2. Time at which drink absorption rate returned to 0 (t2) [60 minutes]

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

  3. Time at which 50% of drink was absorbed (t1/2) [60 minutes]

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

  4. Maximum absorption rate of drink [60 minutes]

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

  5. 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. Plasma glucose concentration [60 minutes]

    Determined from venous blood samples collected before and after drink ingestion

  4. Plasma lactate concentration [60 minutes]

    Determined from venous blood samples collected before and after drink ingestion

  5. Plasma creatinine concentration [60 minutes]

    Determined from venous blood samples collected before and after drink ingestion

  6. Plasma amino acid concentration [60 minutes]

    Determined from venous blood samples collected before and after drink ingestion

  7. Urinary specific gravity [60 minutes]

    Determined from urine samples collected before and 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:
NCT04819334
Other Study ID Numbers:
  • LEON3151
First Posted:
Mar 26, 2021
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
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 Feb 25, 2022