Beer for Endurance Exercise Recovery

Study Overview
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Brief Summary
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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].

Official Title
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Potential Impacts of Beer on Post-Race Ultramarathon Athletes

Conditions
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Hyponatremia

Intervention / Treatment
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* Other: Alcoholic Beer
* Other: Non alcoholic beer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sodium level pre and post intervention |  | One hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol