Beverage Hydration Index: Assessment of Four Rehydration Solutions
Status
Completed
Conditions
Hydration
Treatments
Dietary Supplement: Water
Dietary Supplement: Sugar Free
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free with Amino Acids
Details and patient eligibility
About
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.
Full 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.
Enrollment
28 patients
Sex
All
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
28 participants in 24 patient groups
Water, Multiplier, Sugar with Amino Acids, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Water, Multiplier, Sugar Free, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Water, Sugar with Amino Acids, Multiplier, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Water, Sugar with Amino Acids, Sugar Free, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Water, Sugar Free, Multiplier, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Water, Sugar Free, Sugar with Amino Acids, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Water, Sugar with Amino Acids, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Water, Sugar Free, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Sugar with Amino Acids, Water, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Sugar with Amino Acids, Sugar Free, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Sugar Free, Water, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Multiplier, Sugar Free, Sugar with Amino Acids, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Water, Multiplier, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Water, Sugar Free, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Multiplier, Water, and Sugar Free
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Multiplier, Sugar Free, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Sugar Free, Water, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar with Amino Acids, Sugar Free, Multiplier, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Water, Multiplier, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Water, Sugar with Amino Acids, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Multiplier, Water, and Sugar with Amino Acids
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Multiplier, Sugar with Amino Acids, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Sugar with Amino Acids, Water, and Multiplier
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Sugar Free, Sugar with Amino Acids, Multiplier, and Water
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Sugar Free with Amino Acids
Dietary Supplement: Multiplier
Dietary Supplement: Sugar Free
Dietary Supplement: Water
Trial contacts and locations
1
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Central trial contact
Jackie Pence, PhD
Data sourced from clinicaltrials.gov
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