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Beverage Hydration Index: Assessment of Four Rehydration Solutions

Beverage Hydration Index: Assessment of Four Rehydration Solutions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06272435
Enrollment
28
Registered
2024-02-22
Start date
2023-12-23
Completion date
2024-09-06
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydration

Keywords

Liquid IV, Electrolyte, Beverage Hydration Index

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.

Interventions

DIETARY_SUPPLEMENTMultiplier

Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.

DIETARY_SUPPLEMENTSugar Free

Subjects will consume 1 Liter (2 servings) of experimental Sugar Free Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.

DIETARY_SUPPLEMENTSugar Free with Amino Acids

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.

DIETARY_SUPPLEMENTWater

Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.

Sponsors

University of Memphis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup.

Intervention model description

Semi-blinded, placebo controlled, crossover design

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Beverage Hydration Index0 minutes after beverage consumptionBeverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.

Secondary

MeasureTime frameDescription
Urine Osmolality0 minutes before beverage consumptionUrine Osmolality will be measured in milliosmoles per kilogram of water.
Urine Sodium0 minutes before beverage consumptionUrine Sodium will be measured in millimoles per liter.
Urine Potassium0 minutes before beverage consumptionUrine Potassium will be measured in millimoles per liter.
Urine Specific Gravity150 minutes before beverage consumptionUrine Specific Gravity will be measured via refractometry.
Net Fluid Balance0 minutes after beverage consumptionNet Fluid balance will be calculated subtracting total urine collected from total liquid consumed
Potassium balance0 minutes after beverage consumptionPotassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.
Body Mass0 minutes before beverage consumptionBody Mass in kilograms will be measured using a digital scale
Mood and Digestive Questionnaire0 minutes before beverage consumptionSubjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
Sodium balance0 minutes after beverage consumptionSodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026