HealthyNCT03262597
"Beverage Hydration Index" of Commercial Therapeutic Beverages
A study testing enterade, Pedialyte and Gatorade in people with Healthy, run by Sonoma State University at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- enterade, Pedialyte and Gatorade
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- Aged 18-35
- BMI 18-27 kg/m2
- No known cardiovascular, renal or metabolic disease
- Moderately active
- Moderate alcohol use
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sonoma State Univrsity
Rohnert Park, California, 94928
About this study
Official title: 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).
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteradeOther
Subjects will consume enterade, which is an amino acid-based oral rehydration solution.
PedialyteOther
Subjects will consume Pedialyte
GatoradeOther
Subjects will consume Gatorade
WaterOther
Subjects will consume water as the control beverage
| Study group | Role | What they receive |
|---|---|---|
| Beverage Hydration Index of beverages | Experimental | Subjects will consume 4 different beverages to obtain the beverage hydration index. Receives: Other: enterade; Other: Pedialyte; Other: Gatorade; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beverage hydration index
beverage hydration index
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start17 Feb 2017
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Responsible party
- Principal investigator, Kurt Sollanek, Sonoma State University
- Investigators
- Kurt J Sollanek, Ph.D., Principal investigator, Sonoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262597
- Sponsor's protocol ID
- IRB Application #2667
- Status last verified
- Mar 2018
- First submitted
- 23 Aug 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29635499
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beverage Hydration Index of Three Commercial Oral Rehydration Therapy ORT Beverages
- ClinicalTrials.gov ID
- NCT03262597
- Acronym / sponsor ID
- IRB Application #2667
- Conditions
- Healthy
- Keywords
- fluid balance, dehydration, rehydration, electrolytes, urine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sonoma State UniversityUniversity, hospital or other
- Collaborators
- Entrinsic Bioscience Inc.
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
| Arm | Type | Receives |
|---|---|---|
| Beverage Hydration Index of beverages | Experimental | Other: enterade, Other: Pedialyte, Other: Gatorade, Other: WaterSubjects will consume 4 different beverages to obtain the beverage hydration index. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female
- Aged 18-35
- BMI 18-27 kg/m2
- No known cardiovascular, renal or metabolic disease
- Moderately active
Key exclusion criteria (8 listed)
- Overweight or obese (BMI >27 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteradeSubjects will consume enterade, which is an amino acid-based oral rehydration solution. | Other | Beverage Hydration Index of beverages |
| PedialyteSubjects will consume Pedialyte | Other | Beverage Hydration Index of beverages |
| GatoradeSubjects will consume Gatorade | Other | Beverage Hydration Index of beverages |
| WaterSubjects will consume water as the control beverage | Other | Beverage Hydration Index of beverages |
Primary outcome
Beverage hydration index
Time frame: 4 hours
beverage hydration index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 29635499Sollanek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt J Sollanek, Ph.D. principal investigator
Sonoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enterade, Pedialyte and Gatorade in people with Healthy, run by Sonoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beverage hydration index (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.