Beer for Endurance Exercise Recovery

Hyponatremia Clinical Trial

— BEER  

Official title:

Potential Impacts of Beer on Post-Race Ultramarathon Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032445
• Other study ID #: Beer Trial
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: April 25, 2018
• Start date: March 1, 2017
• Est. completion date: May 21, 2017

Study information

• Verified date: April 2018
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 21, 2017
• Est. primary completion date: May 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyponatremia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sodium level pre and post intervention		One hour
Secondary	Measurement of urine output		One hour
Secondary	Number of participants with abnormal laboratory values		One hour
Secondary	Level of cognition	Cognitive level determined by assessment of clock drawing test.	Within one month of intervention