Rate of Water Appearance/Delivery in the BloodNCT04509388
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
A study testing Composition of Sports Drink in people with Rate of Water Appearance/Delivery in the Blood and Water Balance, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rate of Water Appearance/Delivery in the Blood, Water Balance
- What is being tested?
- Composition of Sports Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2020to 14 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally fit and healthy (determined by health screen questionnaire)
- Recreationally active (minimum 3 hours of physical activity per week including walking)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
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.
- Being tested
- Composition of Sports Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Commercially Available Sports Drink A | Placebo comparator | A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes Receives: Other: Composition of Sports Drink |
| Commercially Available Sports Drink B | Experimental | A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes. Receives: 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). Receives: Other: Composition of Sports Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time at which drink absorption rate was maximum (t1)
Determined from D2O values in venous blood samples collected before and after drink ingestion
Measured: 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
Measured: 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
Measured: 60 minutes
Maximum absorption rate of drink
Determined from D2O values in venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Area under the curve for D2O
Determined from D2O values in venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Secondary outcomes (10)
Plasma volume
Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma osmolality
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma sodium concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma potassium concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma glucose concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma lactate concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma creatinine concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Plasma amino acid concentration
Determined from venous blood samples collected before and after drink ingestion
Measured: 60 minutes
Urinary D2O concentration
Determined from urine samples collected before and after drink ingestion
Measured: 60 minutes
Urinary specific gravity
Determined from urine samples collected before and after drink ingestion
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start10 Aug 2020
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of Water Appearance/Delivery in the BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomised, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Entrinsic Beverage Company LLC
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509388
- Sponsor's protocol ID
- LEON1416
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
- ClinicalTrials.gov ID
- NCT04509388
- Acronym / sponsor ID
- LEON1416
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Entrinsic Beverage Company LLC
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind, randomised, crossover design
| Arm | Type | Receives |
|---|---|---|
| Commercially Available Sports Drink A | Placebo comparator | Other: Composition of Sports DrinkA commercially available sports water, with small amounts of flavouring, sweetener and electrolytes |
| Commercially Available Sports Drink B | Experimental | Other: Composition of Sports DrinkA commercially available sports water, with small amounts of flavouring, sweetener and electrolytes. |
| Commercially Available Sports Drink A with added Amino Acids | Experimental | Other: Composition of Sports DrinkThe 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally fit and healthy (determined by health screen questionnaire)
- Recreationally active (minimum 3 hours of physical activity per week including walking)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composition of Sports DrinkThe composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid. | Other | Commercially Available Sports Drink A, Commercially Available Sports Drink A with added Amino Acids, Commercially Available Sports Drink B |
Primary outcome
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
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
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
Maximum absorption rate of drink
Time frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
Area under the curve for D2O
Time frame: 60 minutes
Determined from D2O values in venous blood samples collected before and after drink ingestion
10 secondary outcomes
Plasma volume
Time frame: 60 minutes
Plasma osmolality
Time frame: 60 minutes
Plasma sodium concentration
Time frame: 60 minutes
Plasma potassium concentration
Time frame: 60 minutes
Plasma glucose concentration
Time frame: 60 minutes
Plasma lactate concentration
Time frame: 60 minutes
Plasma creatinine concentration
Time frame: 60 minutes
Plasma amino acid concentration
Time frame: 60 minutes
Urinary D2O concentration
Time frame: 60 minutes
Urinary specific gravity
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composition of Sports Drink in people with Rate of Water Appearance/Delivery in the Blood and Water Balance, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time at which drink absorption rate was maximum (t1) (time frame: 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.