Clinical trial NCT06272435: Beverage Hydration Index: Assessment of Four Rehydration Solutions
Official title: Beverage Hydration Index: Assessment of Four Rehydration Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Keywords: Liquid IV
Electrolyte
Beverage Hydration Index
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Semi-blinded, placebo controlled, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beverage Hydration Index
timeFrame: 0 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 60 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 120 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 180 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 240 minutes after beverage consumption
Secondary outcomes:
measure: Net Fluid Balance
timeFrame: 0 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 60 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 120 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 180 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 240 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 0 minutes before beverage consumption
measure: Urine Osmolality
timeFrame: 0 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 60 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 120 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 180 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 240 minutes after beverage consumption
measure: Urine Sodium
timeFrame: 0 minutes before beverage consumption
measure: Urine Sodium
timeFrame: 0 minutes after beverage consumption
measure: Urine Sodium
timeFrame: 60 minutes after beverage consumption
measure: Urine Sodium
timeFrame: 120 minutes after beverage consumption
measure: Urine Sodium
timeFrame: 180 minutes after beverage consumption
measure: Urine Sodium
timeFrame: 240 minutes after beverage consumption
measure: Urine Potassium
timeFrame: 0 minutes before beverage consumption
measure: Urine Potassium
timeFrame: 0 minutes after beverage consumption
measure: Urine Potassium
timeFrame: 60 minutes after beverage consumption
measure: Urine Potassium
timeFrame: 120 minutes after beverage consumption
measure: Urine Potassium
timeFrame: 180 minutes after beverage consumption
measure: Urine Potassium
timeFrame: 240 minutes after beverage consumption
measure: Urine Specific Gravity
timeFrame: 150 minutes before beverage consumption
measure: Urine Specific Gravity
timeFrame: 0 minutes before beverage consumption urine
measure: Urine Specific Gravity
timeFrame: 0 minutes after beverage consumption urine
measure: Urine Specific Gravity
timeFrame: 60 minutes after beverage consumption urine
measure: Urine Specific Gravity
timeFrame: 120 minutes after beverage consumption urine
measure: Urine Specific Gravity
timeFrame: 180 minutes after beverage consumption urine
measure: Urine Specific Gravity
timeFrame: 240 minutes after beverage consumption urine
measure: Sodium balance
timeFrame: 0 minutes after beverage consumption
measure: Sodium balance
timeFrame: 60 minutes after beverage consumption
measure: Sodium balance
timeFrame: 120 minutes after beverage consumption
measure: Sodium balance
timeFrame: 180 minutes after beverage consumption
measure: Sodium balance
timeFrame: 240 minutes after beverage consumption
measure: Potassium balance
timeFrame: 0 minutes after beverage consumption
measure: Potassium balance
timeFrame: 60 minutes after beverage consumption
measure: Potassium balance
timeFrame: 120 minutes after beverage consumption
measure: Potassium balance
timeFrame: 180 minutes after beverage consumption
measure: Potassium balance
timeFrame: 240 minutes after beverage consumption
measure: Body Mass
timeFrame: 0 minutes before beverage consumption
measure: Body Mass
timeFrame: 240 minutes after beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 0 minutes before beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 0 minutes after beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 60 minutes after beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 120 minutes after beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 180 minutes after beverage consumption
measure: Mood and Digestive Questionnaire
timeFrame: 240 minutes after beverage consumption
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: Center for Nutraceutical and Dietary Supplement Research
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: