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Beer for Endurance Exercise Recovery (BEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032445
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jeremy Joslin, MD, State University of New York - Upstate Medical University

Brief Summary:
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].

Condition or disease Intervention/treatment Phase
Hyponatremia Other: Alcoholic Beer Other: Non alcoholic beer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Potential Impacts of Beer on Post-Race Ultramarathon Athletes
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 21, 2017
Actual Study Completion Date : May 21, 2017

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.




Primary Outcome Measures :
  1. Changes in sodium level pre and post intervention [ Time Frame: One hour ]

Secondary Outcome Measures :
  1. Measurement of urine output [ Time Frame: One hour ]
  2. Number of participants with abnormal laboratory values [ Time Frame: One hour ]
  3. Level of cognition [ Time Frame: Within one month of intervention ]
    Cognitive level determined by assessment of clock drawing test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032445


Locations
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United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
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Principal Investigator: Jeremy Joslin, MD SUNY Upstate Medicial University
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Responsible Party: Jeremy Joslin, MD, Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03032445    
Other Study ID Numbers: Beer Trial
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jeremy Joslin, MD, State University of New York - Upstate Medical University:
Body Water/physiology
Hyponatremia/etiology
Physical Exertion/physiology
Running/physiology
Sodium/blood
Ethanol
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases