- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06272435
Beverage Hydration Index: Assessment of Four Rehydration Solutions
Study Overview
Status
Conditions
Detailed Description
Many attempts have been made to improve and measure the hydration status of active individuals. This typically involves the ingestion of fluids leading up to activity (typically plain water), as well as the ingestion of fluids during the activity itself (water, along with a diluted carbohydrate/electrolyte beverage). This approach seems to work well; however, some debate remains over what the best fluid is to consume, in particular related to the macronutrient type and the specific electrolyte mix.
No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jackie Pence, PhD
- Phone Number: 9016781547
- Email: jpence1@memphis.edu
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38152
- Recruiting
- Center for Nutraceutical and Dietary Supplement Research
-
Contact:
- Jackie Pence, Ph.D.
- Phone Number: 901-678-1547
- Email: jpence1@memphis.edu
-
Principal Investigator:
- Richard J Bloomer, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- body mass index (BMI) <35 kilgrams per square meter
- consistent dietary intake and exercise throughout study period
- consumes 2 liters (women) or 2.5 liters (men) of water per day prior to study visits
- able to fast for 15 hours
Exclusion Criteria:
- sensitivity or be allergic to any components of the study product they will be excluded.
- tobacco user
- specialized diet (low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting, etc.)
- caffeine consumption within 12 hours of study visit
- strenuous activity within 24 hours of study visit
- history or presence of a clinically relevant (that required or requires treatment) cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder
- conditions that alter fluid balance or electrolytes/hydration status
- consuming any medication which may alter fluid retention/electrolyte levels such as sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium.
- consuming nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening).
- employee of Liquid IV
- be enrolled in another clinical study within 30 days of the first study visit
- active infection or illness of any kind
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Water, Multiplier, Sugar with Amino Acids, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Water, Multiplier, Sugar Free, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Water, Sugar with Amino Acids, Multiplier, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Water, Sugar with Amino Acids, Sugar Free, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Water, Sugar Free, Multiplier, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Water, Sugar Free, Sugar with Amino Acids, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Water, Sugar with Amino Acids, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Water, Sugar Free, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Sugar with Amino Acids, Water, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Sugar with Amino Acids, Sugar Free, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Sugar Free, Water, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Multiplier, Sugar Free, Sugar with Amino Acids, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Water, Multiplier, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Water, Sugar Free, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Multiplier, Water, and Sugar Free
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Multiplier, Sugar Free, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Sugar Free, Water, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar with Amino Acids, Sugar Free, Multiplier, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Water, Multiplier, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Water, Sugar with Amino Acids, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Multiplier, Water, and Sugar with Amino Acids
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Multiplier, Sugar with Amino Acids, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Sugar with Amino Acids, Water, and Multiplier
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
Experimental: Sugar Free, Sugar with Amino Acids, Multiplier, and Water
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will then consume the assigned treatment (one treatment per visit in order above) and additional experimental measurements will be collected.
|
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter (2 servings) of commercially available Sugar Free Hydration Multiplier product that contains amino acids at a rate of 250 milliliters per 7.5 minutes.
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beverage Hydration Index
Time Frame: 0 minutes after beverage consumption
|
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
|
0 minutes after beverage consumption
|
Beverage Hydration Index
Time Frame: 60 minutes after beverage consumption
|
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
|
60 minutes after beverage consumption
|
Beverage Hydration Index
Time Frame: 120 minutes after beverage consumption
|
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
|
120 minutes after beverage consumption
|
Beverage Hydration Index
Time Frame: 180 minutes after beverage consumption
|
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
|
180 minutes after beverage consumption
|
Beverage Hydration Index
Time Frame: 240 minutes after beverage consumption
|
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
|
240 minutes after beverage consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net Fluid Balance
Time Frame: 0 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
0 minutes after beverage consumption
|
Net Fluid Balance
Time Frame: 60 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
60 minutes after beverage consumption
|
Net Fluid Balance
Time Frame: 120 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
120 minutes after beverage consumption
|
Net Fluid Balance
Time Frame: 180 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
180 minutes after beverage consumption
|
Net Fluid Balance
Time Frame: 240 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
240 minutes after beverage consumption
|
Urine Osmolality
Time Frame: 0 minutes before beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes before beverage consumption
|
Urine Osmolality
Time Frame: 0 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes after beverage consumption
|
Urine Osmolality
Time Frame: 60 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
60 minutes after beverage consumption
|
Urine Osmolality
Time Frame: 120 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
120 minutes after beverage consumption
|
Urine Osmolality
Time Frame: 180 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
180 minutes after beverage consumption
|
Urine Osmolality
Time Frame: 240 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
240 minutes after beverage consumption
|
Urine Sodium
Time Frame: 0 minutes before beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
0 minutes before beverage consumption
|
Urine Sodium
Time Frame: 0 minutes after beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
0 minutes after beverage consumption
|
Urine Sodium
Time Frame: 60 minutes after beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
60 minutes after beverage consumption
|
Urine Sodium
Time Frame: 120 minutes after beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
120 minutes after beverage consumption
|
Urine Sodium
Time Frame: 180 minutes after beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
180 minutes after beverage consumption
|
Urine Sodium
Time Frame: 240 minutes after beverage consumption
|
Urine Sodium will be measured in millimoles per liter.
|
240 minutes after beverage consumption
|
Urine Potassium
Time Frame: 0 minutes before beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
0 minutes before beverage consumption
|
Urine Potassium
Time Frame: 0 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
0 minutes after beverage consumption
|
Urine Potassium
Time Frame: 60 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
60 minutes after beverage consumption
|
Urine Potassium
Time Frame: 120 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
120 minutes after beverage consumption
|
Urine Potassium
Time Frame: 180 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
180 minutes after beverage consumption
|
Urine Potassium
Time Frame: 240 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per liter.
|
240 minutes after beverage consumption
|
Urine Specific Gravity
Time Frame: 150 minutes before beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
150 minutes before beverage consumption
|
Urine Specific Gravity
Time Frame: 0 minutes before beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
0 minutes before beverage consumption urine
|
Urine Specific Gravity
Time Frame: 0 minutes after beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
0 minutes after beverage consumption urine
|
Urine Specific Gravity
Time Frame: 60 minutes after beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
60 minutes after beverage consumption urine
|
Urine Specific Gravity
Time Frame: 120 minutes after beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
120 minutes after beverage consumption urine
|
Urine Specific Gravity
Time Frame: 180 minutes after beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
180 minutes after beverage consumption urine
|
Urine Specific Gravity
Time Frame: 240 minutes after beverage consumption urine
|
Urine Specific Gravity will be measured via refractometry.
|
240 minutes after beverage consumption urine
|
Sodium balance
Time Frame: 0 minutes after beverage consumption
|
Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.
|
0 minutes after beverage consumption
|
Sodium balance
Time Frame: 60 minutes after beverage consumption
|
Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.
|
60 minutes after beverage consumption
|
Sodium balance
Time Frame: 120 minutes after beverage consumption
|
Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.
|
120 minutes after beverage consumption
|
Sodium balance
Time Frame: 180 minutes after beverage consumption
|
Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.
|
180 minutes after beverage consumption
|
Sodium balance
Time Frame: 240 minutes after beverage consumption
|
Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.
|
240 minutes after beverage consumption
|
Potassium balance
Time Frame: 0 minutes after beverage consumption
|
Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
|
0 minutes after beverage consumption
|
Potassium balance
Time Frame: 60 minutes after beverage consumption
|
Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
|
60 minutes after beverage consumption
|
Potassium balance
Time Frame: 120 minutes after beverage consumption
|
Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
|
120 minutes after beverage consumption
|
Potassium balance
Time Frame: 180 minutes after beverage consumption
|
Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
|
180 minutes after beverage consumption
|
Potassium balance
Time Frame: 240 minutes after beverage consumption
|
Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
|
240 minutes after beverage consumption
|
Body Mass
Time Frame: 0 minutes before beverage consumption
|
Body Mass in kilograms will be measured using a digital scale
|
0 minutes before beverage consumption
|
Body Mass
Time Frame: 240 minutes after beverage consumption
|
Body Mass in kilograms will be measured using a digital scale
|
240 minutes after beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 0 minutes before beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
0 minutes before beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 0 minutes after beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
0 minutes after beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 60 minutes after beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
60 minutes after beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 120 minutes after beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
120 minutes after beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 180 minutes after beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
180 minutes after beverage consumption
|
Mood and Digestive Questionnaire
Time Frame: 240 minutes after beverage consumption
|
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
|
240 minutes after beverage consumption
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Bloomer, PhD, Center for Nutraceutical and Dietary Supplement Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO-FY2024-64
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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