NCT04509388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

August 6, 2020

Last Update Submit

February 12, 2021

Conditions

Rate of Water Appearance/Delivery in the BloodWater Balance

Outcome Measures

Primary Outcomes (5)

  • Time at which drink absorption rate was maximum (t1)

    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)

    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)

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

    60 minutes

  • Maximum absorption rate of drink

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

    60 minutes

  • Area under the curve for D2O

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

    60 minutes

Secondary Outcomes (10)

  • Plasma volume

    60 minutes

  • Plasma osmolality

    60 minutes

  • Plasma sodium concentration

    60 minutes

  • Plasma potassium concentration

    60 minutes

  • Plasma glucose concentration

    60 minutes

  • +5 more secondary outcomes

Study Arms (3)

Commercially Available Sports Drink A

PLACEBO COMPARATOR

A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes

Other: Composition of Sports Drink

Commercially Available Sports Drink B

EXPERIMENTAL

A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes.

Other: Composition of Sports Drink

Commercially Available Sports Drink A with added Amino Acids

EXPERIMENTAL

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

Interventions

Composition of Sports DrinkOTHER

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

Commercially Available Sports Drink ACommercially Available Sports Drink A with added Amino AcidsCommercially Available Sports Drink B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double-blind, randomised, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 12, 2020

Study Start

August 10, 2020

Primary Completion

October 14, 2020

Study Completion

October 14, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations

GB(1)