NCT03262597

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

August 23, 2017

Last Update Submit

March 5, 2018

Conditions

Keywords

fluid balancedehydrationrehydrationelectrolytesurine

Outcome Measures

Primary Outcomes (1)

  • Beverage hydration index

    beverage hydration index

    4 hours

Study Arms (1)

Beverage Hydration Index of beverages

EXPERIMENTAL

Subjects will consume 4 different beverages to obtain the beverage hydration index.

Other: enteradeOther: PedialyteOther: GatoradeOther: Water

Interventions

Subjects will consume enterade, which is an amino acid-based oral rehydration solution.

Beverage Hydration Index of beverages

Subjects will consume Pedialyte

Beverage Hydration Index of beverages

Subjects will consume Gatorade

Beverage Hydration Index of beverages
WaterOTHER

Subjects will consume water as the control beverage

Beverage Hydration Index of beverages

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonoma State Univrsity

Rohnert Park, California, 94928, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dehydration

Interventions

gatoradeWater

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Kurt J Sollanek, Ph.D.

    Sonoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

February 17, 2017

Primary Completion

April 14, 2017

Study Completion

April 14, 2017

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations