Beverage Hydration Index: Assessment of Four Rehydration Solutions
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2023
CompletedFirst Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2024
CompletedDecember 16, 2024
December 1, 2024
9 months
February 1, 2024
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Beverage Hydration Index
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
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
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
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
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 Outcomes (48)
Net Fluid Balance
0 minutes after beverage consumption
Net Fluid Balance
60 minutes after beverage consumption
Net Fluid Balance
120 minutes after beverage consumption
Net Fluid Balance
180 minutes after beverage consumption
Net Fluid Balance
240 minutes after beverage consumption
- +43 more secondary outcomes
Study Arms (24)
Water, Multiplier, Sugar with Amino Acids, and Sugar Free
EXPERIMENTALSubjects 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.
Water, Multiplier, Sugar Free, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Water, Sugar with Amino Acids, Multiplier, and Sugar Free
EXPERIMENTALSubjects 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.
Water, Sugar with Amino Acids, Sugar Free, and Multiplier
EXPERIMENTALSubjects 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.
Water, Sugar Free, Multiplier, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Water, Sugar Free, Sugar with Amino Acids, and Multiplier
EXPERIMENTALSubjects 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.
Multiplier, Water, Sugar with Amino Acids, and Sugar Free
EXPERIMENTALSubjects 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.
Multiplier, Water, Sugar Free, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Multiplier, Sugar with Amino Acids, Water, and Sugar Free
EXPERIMENTALSubjects 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.
Multiplier, Sugar with Amino Acids, Sugar Free, and Water
EXPERIMENTALSubjects 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.
Multiplier, Sugar Free, Water, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Multiplier, Sugar Free, Sugar with Amino Acids, and Water
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Water, Multiplier, and Sugar Free
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Water, Sugar Free, and Multiplier
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Multiplier, Water, and Sugar Free
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Multiplier, Sugar Free, and Water
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Sugar Free, Water, and Multiplier
EXPERIMENTALSubjects 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.
Sugar with Amino Acids, Sugar Free, Multiplier, and Water
EXPERIMENTALSubjects 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.
Sugar Free, Water, Multiplier, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Sugar Free, Water, Sugar with Amino Acids, and Multiplier
EXPERIMENTALSubjects 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.
Sugar Free, Multiplier, Water, and Sugar with Amino Acids
EXPERIMENTALSubjects 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.
Sugar Free, Multiplier, Sugar with Amino Acids, and Water
EXPERIMENTALSubjects 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.
Sugar Free, Sugar with Amino Acids, Water, and Multiplier
EXPERIMENTALSubjects 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.
Sugar Free, Sugar with Amino Acids, Multiplier, and Water
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bloomer, PhD
Center for Nutraceutical and Dietary Supplement Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of College of Health Sciences
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 22, 2024
Study Start
December 23, 2023
Primary Completion
September 6, 2024
Study Completion
September 6, 2024
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share