Clinical trial NCT06733532: Comparison of the Beverage Hydration Index of Different Solutions
Official title: Comparison of the Beverage Hydration Index of Different Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: semi-blinded
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It 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 beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

Detailed description: The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It 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 beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) \<35 kg/m2 (not morbidly obese)
* Cannot have a sensitivity or be allergic to any components of the study product they will be excluded.
* non-tobacco user
* cannot be following a specialized dietary pattern that may alter findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.)
* willing to replicate the same dietary intake/activity (exercise) level for each day before a lab visit excluding screening
* Will consume a minimum of 2 liters (women) or 2.5 liters (men) of water per day, on each day prior to experimental lab visits (excluding screening)
* Will arrive to lab for visits euhydrated (USG 1.005-1.020)
* Will not consume alcohol-containing beverages within 24 hours of testing
* Will not consume caffeine-containing beverages within 12 hours of testing
* can fast (consume water/treatments only) for 15 hours (10 hours prior to lab visits not including screening)
* avoid strenuous activity for 24 hours prior to study visits excluding screening
* Will not have a 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 (reviewed by Nurse practitioner)
* Will not have other conditions that is likely to alter fluid balance or be negatively affected by changing electrolyte levels/hydration status (as determined by Nurse practitioner)
* Is not 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. (Medications will be reviewed by Nurse practitioner)
* Will not consume nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening.
* cannot be enrolled in another clinical study within 30 days of the first study visit
* without 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
measure: Urine Specific Gravity
timeFrame: 0 minutes after beverage consumption
measure: Urine Specific Gravity
timeFrame: 60 minutes after beverage consumption
measure: Urine Specific Gravity
timeFrame: 120 minutes after beverage consumption
measure: Urine Specific Gravity
timeFrame: 180 minutes after beverage consumption
measure: Urine Specific Gravity
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
measure: Diastolic Blood Pressure
timeFrame: 0 minutes before beverage consumption
measure: Diastolic Blood Pressure
timeFrame: 0 minutes after beverage consumption
measure: Diastolic Blood Pressure
timeFrame: 60 minutes after beverage consumption
measure: Diastolic Blood Pressure
timeFrame: 120 minutes after beverage consumption
measure: Diastolic Blood Pressure
timeFrame: 180 minutes after beverage consumption
measure: Diastolic Blood Pressure
timeFrame: 240 minutes after beverage consumption
measure: Systolic Blood Pressure
timeFrame: 0 minutes before beverage consumption
measure: Systolic Blood Pressure
timeFrame: 0 minutes after beverage consumption
measure: Systolic Blood Pressure
timeFrame: 60 minutes after beverage consumption
measure: Systolic Blood Pressure
timeFrame: 120 minutes after beverage consumption
measure: Systolic Blood Pressure
timeFrame: 180 minutes after beverage consumption
measure: Systolic Blood Pressure
timeFrame: 240 minutes after beverage consumption
measure: Heart Rate
timeFrame: 0 minutes before beverage consumption
measure: Heart Rate
timeFrame: 0 minutes after beverage consumption
measure: Heart Rate
timeFrame: 60 minutes after beverage consumption
measure: Heart Rate
timeFrame: 120 minutes after beverage consumption
measure: Heart Rate
timeFrame: 180 minutes after beverage consumption
measure: Heart Rate
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: University of Memphis
name: Richard J Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: