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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03262597
Other study ID # IRB Application #2667
Secondary ID
Status Completed
Phase N/A
First received August 23, 2017
Last updated March 5, 2018
Start date February 17, 2017
Est. completion date April 14, 2017

Study information

Verified date March 2018
Source Sonoma State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 14, 2017
Est. primary completion date April 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
enterade
Subjects will consume enterade, which is an amino acid-based oral rehydration solution.
Pedialyte
Subjects will consume Pedialyte
Gatorade
Subjects will consume Gatorade
Water
Subjects will consume water as the control beverage

Locations

Country Name City State
United States Sonoma State Univrsity Rohnert Park California

Sponsors (2)

Lead Sponsor Collaborator
Sonoma State University Entrinsic Health Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beverage hydration index beverage hydration index 4 hours
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