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Comparison of the Beverage Hydration Index of Different Solutions

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University of Memphis

Status

Completed

Conditions

Hydration

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06733532
PRO-FY2024-372

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

29 participants in 6 patient groups

Propel, Essentia, Smart
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate
Propel, Smart, Essentia
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate
Essentia, Smart, Propel
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate
Essentia, Propel, Smart
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate
Smart, Essentia, Propel
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate
Smart, Propel, Essentia
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Berry Propel Fitness Water
Dietary Supplement: Smart Water
Dietary Supplement: Essentia Hydroboost Raspberry Pomegranate

Trial contacts and locations

1

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Central trial contact

Jackie Pence, PhD

Data sourced from clinicaltrials.gov

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