Beer for Endurance Exercise Recovery (BEER)

April 25, 2018 updated by: Jeremy Joslin, MD, State University of New York - Upstate Medical University

Potential Impacts of Beer on Post-Race Ultramarathon Athletes

Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are eligible, based on inclusion criteria, to participate in this research study that is seeking to determine whether supplementation of beer (alcohol) immediately following a long distance ultramarathon race can positively impact exercise-associated hyponatremia [EAH].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

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

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed informed consent
  • Ability to read and speak English language
  • Age 21 years or older
  • Not considered a vulnerable population, such as pregnant (by history) or cognitively impaired.
  • Able to tolerate needle exposure for blood draw
  • Willing to drink alcoholic or nonalcoholic beer
  • Willing not to eat or drink other than the study fluid during 1 hour study period
  • Participating in 100 mile or 50 mile race
  • To participate in the controlled part of the study the individual must have fully completed either the 100 mile or the 50 mile race.

Exclusion Criteria:

  • Under age 21 years
  • Vulnerable population, such as pregnant (by history) or cognitively impaired
  • Subjects who are alcohol-naive (i.e first exposure to alcohol)
  • Subjects with known familial and/or genetic backgrounds at higher risk for the development of alcohol dependence
  • Subjects should not be seeking treatment for alcohol or drug abuse
  • Subjects who are in general high risk for abuse such as those completing or participating in alcohol or drug abuse programs
  • Subjects who have had a sustained period of abstinence, with history of heavy drinking problems, while living in the community

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcoholic beer
At least 6% alcohol content
Other: Alcoholic Beer
Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
Placebo Comparator: Non alcoholic beer
Less than 0.5% alcohol content
Other: Non alcoholic beer
Subject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in sodium level pre and post intervention
Time Frame: One hour
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of urine output
Time Frame: One hour
One hour
Number of participants with abnormal laboratory values
Time Frame: One hour
One hour
Level of cognition
Time Frame: Within one month of intervention
Cognitive level determined by assessment of clock drawing test.
Within one month of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Investigators

  • Principal Investigator: Jeremy Joslin, MD, SUNY Upstate Medicial University

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)

March 1, 2017

Primary Completion (Actual)

May 21, 2017

Study Completion (Actual)

May 21, 2017

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beer Trial

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

product manufactured in and exported from the U.S.

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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