Comparison of the Beverage Hydration Index of Different Solutions

NCT06733532 | Completed

• 1 other identifier: PRO-FY2024-372
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration

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 (56)

• 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

Study Arms (6)

Propel, Essentia, Smart

EXPERIMENTAL

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Propel, Smart, Essentia

EXPERIMENTAL

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Essentia, Smart, Propel

EXPERIMENTAL

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Essentia, Propel, Smart

ACTIVE COMPARATOR

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Smart, Essentia, Propel

EXPERIMENTAL

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Smart, Propel, Essentia

EXPERIMENTAL

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.

Dietary Supplement: Berry Propel Fitness Water; Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate; Dietary Supplement: Smart Water

Interventions

Berry Propel Fitness Water DIETARY_SUPPLEMENT

Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes

Essentia, Propel, Smart; Essentia, Smart, Propel; Propel, Essentia, Smart; Propel, Smart, Essentia; Smart, Essentia, Propel; Smart, Propel, Essentia

Essentia Hydroboost Raspberry Pomegranate DIETARY_SUPPLEMENT

Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes

Essentia, Propel, Smart; Essentia, Smart, Propel; Propel, Essentia, Smart; Propel, Smart, Essentia; Smart, Essentia, Propel; Smart, Propel, Essentia

Smart Water DIETARY_SUPPLEMENT

Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.

Essentia, Propel, Smart; Essentia, Smart, Propel; Propel, Essentia, Smart; Propel, Smart, Essentia; Smart, Essentia, Propel; Smart, Propel, Essentia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

Study Officials

• Richard J Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: treatments labeled A-C. Subjects will be provided the beverage in plastic cups without product labels
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Model Details: semi-blinded

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: November 21, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 21, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)