Hyponatremia
Conditions
Keywords
Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol
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 \[EAH\].
Interventions
OTHERAlcoholic Beer
Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
OTHERNon 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.
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sodium level pre and post intervention | One hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of urine output | One hour | — |
| Number of participants with abnormal laboratory values | One hour | — |
| Level of cognition | Within one month of intervention | Cognitive level determined by assessment of clock drawing test. |
Countries
United States
Outcome results
None listed