Clinical trial NCT03262597: "Beverage Hydration Index" of Commercial Therapeutic Beverages
Official title: Beverage Hydration Index of Three Commercial Oral Rehydration Therapy ORT Beverages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: fluid balance
dehydration
rehydration
electrolytes
urine
Lead sponsor: Sonoma State University
Sponsor class: OTHER
Collaborators: name: Entrinsic Bioscience Inc.
First posted: 2017-08-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The "beverage hydration index" (BHI) assesses the hydration potential of any consumable fluid relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of beverages never previously tested, including an amino acid-based oral rehydration solution (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water (control).

Detailed description: The "Beverage Hydration Index" (BHI) was created to assess the degree to which beverages "hydrate", by measuring fluid retention after ingesting a 1 liter bolus and comparing it to water. Drinks with carbohydrates and electrolytes would traditionally be expected to score higher on the BHI due to glucose-sodium cotransport at the gut and osmolality approaching isotonicity with blood. One recent study reported that an oral rehydration solution (ORS) scored better than water, but a "sports drink" did not. No "optimal" BHI beverage composition has been described, nor has an optimal osmolality. Recently, a hypotonic amino acid-based rehydration beverage was developed to take advantage of amino acid-sodium cotransport, thus obviating the need for carbohydrate. However, the BHI of this beverage has not yet been assessed. The purpose of this investigation was to assess the hydration potential of this novel beverage in comparison to a commercially available carbohydrate-containing sports drink and oral rehydration solution.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female
* Aged 18-35
* BMI 18-27 kg/m2
* No known cardiovascular, renal or metabolic disease
* Moderately active
* Moderate alcohol use

Exclusion Criteria:

* Overweight or obese (BMI \>27 kg/m2)

  * Competitive athletes during competition season
  * Current or former cardiovascular, renal or metabolic disease
  * Habitual consumption of alcohol (\>21 units/week) or regular (\>1/week) high (10 units) intake\*
  * History of psychiatric illness
  * Actively seeking to gain or lose weight
  * Currently taking prescribed medication

    * Example, a 750 ml bottle of wine at 12% ABV contains 0.750 Liters \* 12 = 9 units

Primary outcomes:
measure: Beverage hydration index
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rohnert Park
country: United States
facility: Sonoma State Univrsity
state: California
Study officials:
affiliation: Sonoma State University
name: Kurt J Sollanek, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sollanek KJ, Tsurumoto M, Vidyasagar S, Kenefick RW, Cheuvront SN. Neither body mass nor sex influences beverage hydration index outcomes during randomized trial when comparing 3 commercial beverages. Am J Clin Nutr. 2018 Apr 1;107(4):544-549. doi: 10.1093/ajcn/nqy005.