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OpenTrials
Completed

NCT Number: NCT04509388

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Composition of Sports Drink

Other

The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Maximum absorption rate of drink

    Time frame: 60 minutes

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

  5. Area under the curve for D2O

    Time frame: 60 minutes

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

Secondary outcomes

  1. Plasma volume

    Time frame: 60 minutes

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

  2. Plasma osmolality

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  3. Plasma sodium concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  4. Plasma potassium concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  5. Plasma glucose concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  6. Plasma lactate concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  7. Plasma creatinine concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  8. Plasma amino acid concentration

    Time frame: 60 minutes

    Determined from venous blood samples collected before and after drink ingestion

  9. Urinary D2O concentration

    Time frame: 60 minutes

    Determined from urine samples collected before and after drink ingestion

  10. Urinary specific gravity

    Time frame: 60 minutes

    Determined from urine samples collected before and after drink ingestion

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • Entrinsic Beverage Company LLC

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.