- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733532
Comparison of the Beverage Hydration Index of Different Solutions
April 5, 2025 updated by: Richard Bloomer, University of Memphis
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38152
- Center for Nutraceutical and Dietary Supplement Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Propel, Essentia, Smart
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
|
Experimental: Propel, Smart, Essentia
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
|
Experimental: Essentia, Smart, Propel
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
|
Active Comparator: Essentia, Propel, Smart
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
|
Experimental: Smart, Essentia, Propel
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
|
Experimental: Smart, Propel, Essentia
Subjects will follow control diet for 24 hours prior to visit.
At the study visit, baseline measures will be collected prior to treatment.
Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
|
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beverage Hydration Index
Time Frame: 0 minutes after beverage consumption
|
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
Time Frame: 60 minutes after beverage consumption
|
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
Time Frame: 120 minutes after beverage consumption
|
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
Time Frame: 180 minutes after beverage consumption
|
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
Time Frame: 240 minutes after beverage consumption
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urine Osmolality
Time Frame: 0 minutes before beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes before beverage consumption
|
|
Urine Osmolality
Time Frame: 0 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 60 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
60 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 120 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
120 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 180 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
180 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 240 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
240 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 150 minutes before beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
150 minutes before beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 0 minutes before beverage consumption
|
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
|
|
Mood and Digestive Questionnaire
Time Frame: 0 minutes after beverage consumption
|
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
|
|
Mood and Digestive Questionnaire
Time Frame: 60 minutes after beverage consumption
|
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
|
|
Mood and Digestive Questionnaire
Time Frame: 120 minutes after beverage consumption
|
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
|
|
Mood and Digestive Questionnaire
Time Frame: 180 minutes after beverage consumption
|
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
|
|
Mood and Digestive Questionnaire
Time Frame: 240 minutes after beverage consumption
|
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
|
|
Net Fluid Balance
Time Frame: 0 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
0 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 60 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
60 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 120 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
120 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 180 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
180 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 240 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
240 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 0 minutes before beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
0 minutes before beverage consumption
|
|
Urine Sodium
Time Frame: 0 minutes after beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
0 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 60 minutes after beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
60 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 120 minutes after beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
120 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 180 minutes after beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
180 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 240 minutes after beverage consumption
|
Urine Sodium will be measure in millimoles per liter.
|
240 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 0 minutes before beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
0 minutes before beverage consumption
|
|
Urine Potassium
Time Frame: 0 minutes after beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
0 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 60 minutes after beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
60 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 120 minutes after beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
120 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 180 minutes after beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
180 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 240 minutes after beverage consumption
|
Urine Potassium will be measure in millimoles per liter.
|
240 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 0 minutes before beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
0 minutes before beverage consumption
|
|
Urine Specific Gravity
Time Frame: 0 minutes after beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
0 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 60 minutes after beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
60 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 120 minutes after beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
120 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 180 minutes after beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
180 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 240 minutes after beverage consumption
|
Urine Specific Gravity will be measured via refractometry.
|
240 minutes after beverage consumption
|
|
Body Mass
Time Frame: 0 minutes before beverage consumption
|
Body Mass in kilograms will be measured using a digital scale.
|
0 minutes before beverage consumption
|
|
Body Mass
Time Frame: 240 minutes after beverage consumption
|
Body Mass in kilograms will be measured using a digital scale.
|
240 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
0 minutes before beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
0 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
60 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
120 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
180 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
240 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
0 minutes before beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
0 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
60 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
120 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
180 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
|
240 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 0 minutes before beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
0 minutes before beverage consumption
|
|
Heart Rate
Time Frame: 0 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
0 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 60 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
60 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 120 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
120 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 180 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
180 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 240 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff.
|
240 minutes after beverage consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard J Bloomer, PhD, University of Memphis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2024
Primary Completion (Actual)
March 6, 2025
Study Completion (Actual)
March 21, 2025
Study Registration Dates
First Submitted
December 10, 2024
First Submitted That Met QC Criteria
December 10, 2024
First Posted (Actual)
December 13, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 5, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- PRO-FY2024-372
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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