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OpenTrials
Completed

NCT Number: NCT06733532

Comparison of the Beverage Hydration Index of Different Solutions

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.

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Key information

Conditions

Hydration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Smart Water

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Urine Osmolality

    Time frame: 0 minutes before beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  7. Urine Osmolality

    Time frame: 0 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  8. Urine Osmolality

    Time frame: 60 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  9. Urine Osmolality

    Time frame: 120 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  10. Urine Osmolality

    Time frame: 180 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  11. Urine Osmolality

    Time frame: 240 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  12. Urine Sodium

    Time frame: 0 minutes before beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  13. Urine Sodium

    Time frame: 0 minutes after beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  14. Urine Sodium

    Time frame: 60 minutes after beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  15. Urine Sodium

    Time frame: 120 minutes after beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  16. Urine Sodium

    Time frame: 180 minutes after beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  17. Urine Sodium

    Time frame: 240 minutes after beverage consumption

    Urine Sodium will be measure in millimoles per liter.

  18. Urine Potassium

    Time frame: 0 minutes before beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  19. Urine Potassium

    Time frame: 0 minutes after beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  20. Urine Potassium

    Time frame: 60 minutes after beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  21. Urine Potassium

    Time frame: 120 minutes after beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  22. Urine Potassium

    Time frame: 180 minutes after beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  23. Urine Potassium

    Time frame: 240 minutes after beverage consumption

    Urine Potassium will be measure in millimoles per liter.

  24. Urine Specific Gravity

    Time frame: 150 minutes before beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  25. Urine Specific Gravity

    Time frame: 0 minutes before beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  26. Urine Specific Gravity

    Time frame: 0 minutes after beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  27. Urine Specific Gravity

    Time frame: 60 minutes after beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  28. Urine Specific Gravity

    Time frame: 120 minutes after beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  29. Urine Specific Gravity

    Time frame: 180 minutes after beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  30. Urine Specific Gravity

    Time frame: 240 minutes after beverage consumption

    Urine Specific Gravity will be measured via refractometry.

  31. Body Mass

    Time frame: 0 minutes before beverage consumption

    Body Mass in kilograms will be measured using a digital scale.

  32. Body Mass

    Time frame: 240 minutes after beverage consumption

    Body Mass in kilograms will be measured using a digital scale.

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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)

  38. 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)

  39. Diastolic Blood Pressure

    Time frame: 0 minutes before beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  40. Diastolic Blood Pressure

    Time frame: 0 minutes after beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  41. Diastolic Blood Pressure

    Time frame: 60 minutes after beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  42. Diastolic Blood Pressure

    Time frame: 120 minutes after beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  43. Diastolic Blood Pressure

    Time frame: 180 minutes after beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  44. Diastolic Blood Pressure

    Time frame: 240 minutes after beverage consumption

    Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  45. Systolic Blood Pressure

    Time frame: 0 minutes before beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  46. Systolic Blood Pressure

    Time frame: 0 minutes after beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  47. Systolic Blood Pressure

    Time frame: 60 minutes after beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  48. Systolic Blood Pressure

    Time frame: 120 minutes after beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  49. Systolic Blood Pressure

    Time frame: 180 minutes after beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  50. Systolic Blood Pressure

    Time frame: 240 minutes after beverage consumption

    Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.

  51. Heart Rate

    Time frame: 0 minutes before beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

  52. Heart Rate

    Time frame: 0 minutes after beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

  53. Heart Rate

    Time frame: 60 minutes after beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

  54. Heart Rate

    Time frame: 120 minutes after beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

  55. Heart Rate

    Time frame: 180 minutes after beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

  56. Heart Rate

    Time frame: 240 minutes after beverage consumption

    Heart rate will be measured in beats per minute using an automated cuff.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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