"Beverage Hydration Index" of Commercial Therapeutic Beve... | NCT03262597

Studies
"Beverage Hydration Index" of Commercial Therapeutic Beverages

NCT03262597

Sponsor

Sonoma State University

Status

Completed

Last Update Posted

Mar 7, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

enterade
Pedialyte
Gatorade
Water

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2017Actual

Primary Completion Date

Apr 14, 2017Actual

Completion Date

Apr 14, 2017Actual

First Submitted Date

Aug 23, 2017

First Submission Date that Met QC Criteria

Aug 23, 2017

First Posted Date

Aug 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2018

Last Update Posted Date

Mar 7, 2018Actual

Name	Class
Entrinsic Bioscience Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beverage Hydration Index of beverages	Experimental	Subjects will consume 4 different beverages to obtain the beverage hydration index.	Other: enterade Other: Pedialyte Other: Gatorade Other: Water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enterade	Other	Subjects will consume enterade, which is an amino acid-based oral rehydration solution.	Beverage Hydration Index of beverages

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Beverage hydration index	beverage hydration index	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt J Sollanek, Ph.D.	Sonoma State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonoma State Univrsity		Rohnert Park	California	94928	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29635499	Derived	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.

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

ID	Term
C011259	gatorade
D014867	Water

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477