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Completed

NCT Number: NCT06272435

Beverage Hydration Index: Assessment of Four Rehydration Solutions

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.

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Key information

Conditions

Hydration

Age range

18 year–45 year

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

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.

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 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

Treatment and study plan

Multiplier

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

Subjects will consume 1 Liter of 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 total urine collected from total liquid consumed

  2. Net Fluid Balance

    Time frame: 60 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  3. Net Fluid Balance

    Time frame: 120 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  4. Net Fluid Balance

    Time frame: 180 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  5. Net Fluid Balance

    Time frame: 240 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from 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 measured in millimoles per liter.

  13. Urine Sodium

    Time frame: 0 minutes after beverage consumption

    Urine Sodium will be measured in millimoles per liter.

  14. Urine Sodium

    Time frame: 60 minutes after beverage consumption

    Urine Sodium will be measured in millimoles per liter.

  15. Urine Sodium

    Time frame: 120 minutes after beverage consumption

    Urine Sodium will be measured in millimoles per liter.

  16. Urine Sodium

    Time frame: 180 minutes after beverage consumption

    Urine Sodium will be measured in millimoles per liter.

  17. Urine Sodium

    Time frame: 240 minutes after beverage consumption

    Urine Sodium will be measured in millimoles per liter.

  18. Urine Potassium

    Time frame: 0 minutes before beverage consumption

    Urine Potassium will be measured in millimoles per liter.

  19. Urine Potassium

    Time frame: 0 minutes after beverage consumption

    Urine Potassium will be measured in millimoles per liter.

  20. Urine Potassium

    Time frame: 60 minutes after beverage consumption

    Urine Potassium will be measured in millimoles per liter.

  21. Urine Potassium

    Time frame: 120 minutes after beverage consumption

    Urine Potassium will be measured in millimoles per liter.

  22. Urine Potassium

    Time frame: 180 minutes after beverage consumption

    Urine Potassium will be measured in millimoles per liter.

  23. Urine Potassium

    Time frame: 240 minutes after beverage consumption

    Urine Potassium will be measured 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

    Urine Specific Gravity will be measured via refractometry.

  26. Urine Specific Gravity

    Time frame: 0 minutes after beverage consumption urine

    Urine Specific Gravity will be measured via refractometry.

  27. Urine Specific Gravity

    Time frame: 60 minutes after beverage consumption urine

    Urine Specific Gravity will be measured via refractometry.

  28. Urine Specific Gravity

    Time frame: 120 minutes after beverage consumption urine

    Urine Specific Gravity will be measured via refractometry.

  29. Urine Specific Gravity

    Time frame: 180 minutes after beverage consumption urine

    Urine Specific Gravity will be measured via refractometry.

  30. Urine Specific Gravity

    Time frame: 240 minutes after beverage consumption urine

    Urine Specific Gravity will be measured via refractometry.

  31. Sodium balance

    Time frame: 0 minutes after beverage consumption

    Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

  32. Sodium balance

    Time frame: 60 minutes after beverage consumption

    Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

  33. Sodium balance

    Time frame: 120 minutes after beverage consumption

    Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

  34. Sodium balance

    Time frame: 180 minutes after beverage consumption

    Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

  35. Sodium balance

    Time frame: 240 minutes after beverage consumption

    Sodium Balance will be calculated subtracting total sodium in urine from total sodium consumed in beverage.

  36. Potassium balance

    Time frame: 0 minutes after beverage consumption

    Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.

  37. Potassium balance

    Time frame: 60 minutes after beverage consumption

    Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.

  38. Potassium balance

    Time frame: 120 minutes after beverage consumption

    Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.

  39. Potassium balance

    Time frame: 180 minutes after beverage consumption

    Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.

  40. Potassium balance

    Time frame: 240 minutes after beverage consumption

    Potassium Balance will be calculated subtracting total potassium in urine from total potassium consumed in beverage.

  41. Body Mass

    Time frame: 0 minutes before beverage consumption

    Body Mass in kilograms will be measured using a digital scale

  42. Body Mass

    Time frame: 240 minutes after beverage consumption

    Body Mass in kilograms will be measured using a digital scale

  43. 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)

  44. 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)

  45. 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)

  46. 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)

  47. 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)

  48. 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)

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Dec 16, 2024

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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