- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262597
"Beverage Hydration Index" of Commercial Therapeutic Beverages
March 5, 2018 updated by: Kurt Sollanek, Sonoma State University
Beverage Hydration Index of Three Commercial Oral Rehydration Therapy ORT Beverages
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Rohnert Park, California, United States, 94928
- Sonoma State Univrsity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beverage Hydration Index of beverages
Subjects will consume 4 different beverages to obtain the beverage hydration index.
|
Subjects will consume enterade, which is an amino acid-based oral rehydration solution.
Subjects will consume Pedialyte
Subjects will consume Gatorade
Subjects will consume water as the control beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beverage hydration index
Time Frame: 4 hours
|
beverage hydration index
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kurt J Sollanek, Ph.D., Sonoma State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2017
Primary Completion (Actual)
April 14, 2017
Study Completion (Actual)
April 14, 2017
Study Registration Dates
First Submitted
August 23, 2017
First Submitted That Met QC Criteria
August 23, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 5, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB Application #2667
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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