Beverage Hydration Index: Assessment of Four Rehydration Solutions

Hydration Clinical Trial

Official title:

Beverage Hydration Index: Assessment of Four Rehydration Solutions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272435
• Other study ID #: PRO-FY2024-64
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: University of Memphis
• Contact: Jackie Pence, PhD
• Phone: 9016781547
• Email: jpence1[@]memphis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydration

Intervention

Dietary Supplement:
• Multiplier
Subjects will consume 1 Liter (2 servings) of commercially available Hydration Multiplier product at a rate of 250 milliliters per 7.5 minutes.
• Sugar 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.
• Sugar 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.
• Water
Subjects will consume 1 Liter of water at a rate of 250 milliliters per 7.5 minutes.

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Net Fluid Balance	Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed	0 minutes after beverage consumption
Secondary	Net Fluid Balance	Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed	60 minutes after beverage consumption
Secondary	Net Fluid Balance	Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed	120 minutes after beverage consumption
Secondary	Net Fluid Balance	Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed	180 minutes after beverage consumption
Secondary	Net Fluid Balance	Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed	240 minutes after beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	0 minutes before beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	0 minutes after beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	60 minutes after beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	120 minutes after beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	180 minutes after beverage consumption
Secondary	Urine Osmolality	Urine Osmolality will be measured in milliosmoles per kilogram of water.	240 minutes after beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	0 minutes before beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	0 minutes after beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	60 minutes after beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	120 minutes after beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	180 minutes after beverage consumption
Secondary	Urine Sodium	Urine Sodium will be measured in millimoles per liter.	240 minutes after beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	0 minutes before beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	0 minutes after beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	60 minutes after beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	120 minutes after beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	180 minutes after beverage consumption
Secondary	Urine Potassium	Urine Potassium will be measured in millimoles per liter.	240 minutes after beverage consumption
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	150 minutes before beverage consumption
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	0 minutes before beverage consumption urine
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	0 minutes after beverage consumption urine
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	60 minutes after beverage consumption urine
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	120 minutes after beverage consumption urine
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	180 minutes after beverage consumption urine
Secondary	Urine Specific Gravity	Urine Specific Gravity will be measured via refractometry.	240 minutes after beverage consumption urine
Secondary	Sodium balance	Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.	0 minutes after beverage consumption
Secondary	Sodium balance	Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.	60 minutes after beverage consumption
Secondary	Sodium balance	Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.	120 minutes after beverage consumption
Secondary	Sodium balance	Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.	180 minutes after beverage consumption
Secondary	Sodium balance	Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.	240 minutes after beverage consumption
Secondary	Potassium balance	Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.	0 minutes after beverage consumption
Secondary	Potassium balance	Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.	60 minutes after beverage consumption
Secondary	Potassium balance	Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.	120 minutes after beverage consumption
Secondary	Potassium balance	Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.	180 minutes after beverage consumption
Secondary	Potassium balance	Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.	240 minutes after beverage consumption
Secondary	Body Mass	Body Mass in kilograms will be measured using a digital scale	0 minutes before beverage consumption
Secondary	Body Mass	Body Mass in kilograms will be measured using a digital scale	240 minutes after beverage consumption
Secondary	Mood and Digestive Questionnaire	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
Secondary	Mood and Digestive Questionnaire	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
Secondary	Mood and Digestive Questionnaire	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
Secondary	Mood and Digestive Questionnaire	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
Secondary	Mood and Digestive Questionnaire	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
Secondary	Mood and Digestive Questionnaire	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