NCT01974986

Brief Summary

Athletes participating in multiple training sessions a day can be at increased risk of suboptimal hydration and heat illness during their second training session, especially when the environment is hot and humid. With the exception of the absolute volume of water delivered by a rehydration beverage, characteristics of the beverage consumed play a role in the recovery and completeness of rehydration. The amount of sodium in the beverage has been shown to be a primary factor in rehydration. Recently, an effect of the carbohydrate concentration of the beverage was been reported, with its effects mediated by the renal system in response to elevated serum insulin. The purpose of this study is to compare sodium and carbohydrate effects on rehydration and recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

October 28, 2013

Last Update Submit

May 31, 2016

Conditions

Keywords

dehydrationexerciserehydrationsodiumwatercarbohydrate

Outcome Measures

Primary Outcomes (1)

  • Rehydration

    Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.

    8 hours

Secondary Outcomes (1)

  • Body weight

    8 hours

Other Outcomes (1)

  • Total body water

    8 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Water with flavoring and non-nutritive sweetener.

Other: Water with flavoring and non-nutritive sweetener.

High-Na low-CHO beverage

EXPERIMENTAL

Beverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L.

Other: High-Na low-CHO beverage

Low-Na high-CHO beverage

EXPERIMENTAL

Beverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L.

Other: Low-Na high-CHO beverage

Interventions

A volume of fluid (water) was given after exercise to return each subject's body mass (to euhydration).

Placebo

A volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration).

High-Na low-CHO beverage

A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).

Low-Na high-CHO beverage

Eligibility Criteria

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

You may qualify if:

  • Male, age 18-35 y, physically fit, and regularly undergoing exercise training particularly but not exclusively in team sports.

You may not qualify if:

  • "Yes" on PAR-Q survey, symptoms or signs of exercise intolerance, VO2 max \<50 mL/kg/min, smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

DehydrationMotor Activity

Interventions

WaterFlavoring Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsPharmaceutic AidsPharmaceutical PreparationsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Craig Horswill, PhD

    UIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

June 2, 2016

Record last verified: 2016-05

Locations