Rate of Water Appearance/Delivery in the Blood Water Balance Clinical Trial
Official title:
Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
| NCT number | NCT04819334 |
| Other study ID # | LEON3151 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 12, 2021 |
| Est. completion date | May 1, 2021 |
| Verified date | January 2023 |
| Source | Loughborough University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | May 1, 2021 |
| Est. primary completion date | May 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Loughborough University | Loughborough | Leicestershire |
| Lead Sponsor | Collaborator |
|---|---|
| Loughborough University | Entrinsic Beverage Company LLC |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Maximum absorption rate of drink | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes | |
| Primary | Area under the curve for D2O | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma volume | Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma osmolality | Determined from venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma glucose concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma lactate concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma creatinine concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Plasma amino acid concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes | |
| Secondary | Urinary specific gravity | Determined from urine samples collected before and after drink ingestion | 60 minutes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05698849 -
Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
|
N/A |