Clinical trial NCT04509388: Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
Official title: Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rate of Water Appearance/Delivery in the Blood
Water Balance
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Entrinsic Beverage Company LLC
First posted: 2020-08-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomised, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time at which drink absorption rate was maximum (t1)
timeFrame: 60 minutes
measure: Time at which drink absorption rate returned to 0 (t2)
timeFrame: 60 minutes
measure: Time at which 50% of drink was absorbed (t1/2)
timeFrame: 60 minutes
measure: Maximum absorption rate of drink
timeFrame: 60 minutes
measure: Area under the curve for D2O
timeFrame: 60 minutes
Secondary outcomes:
measure: Plasma volume
timeFrame: 60 minutes
measure: Plasma osmolality
timeFrame: 60 minutes
measure: Plasma sodium concentration
timeFrame: 60 minutes
measure: Plasma potassium concentration
timeFrame: 60 minutes
measure: Plasma glucose concentration
timeFrame: 60 minutes
measure: Plasma lactate concentration
timeFrame: 60 minutes
measure: Plasma creatinine concentration
timeFrame: 60 minutes
measure: Plasma amino acid concentration
timeFrame: 60 minutes
measure: Urinary D2O concentration
timeFrame: 60 minutes
measure: Urinary specific gravity
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References: