Beer for Endurance Exercise Recovery (B.E.E.R)

Methods

Summary

This is a randomized, controlled trial of a beer intervention --at least 6% alcohol -- versus nonalcoholic beer.  Upon completion of the race, each study subject will be offered the opportunity to urinate immediately post-race. They will then be required to weigh-in, after which a post-race blood draw will be taken via fingerstick to analyze sodium and other point-of-care testing chem 8+ analysis.

Subjects will then be randomized into Group A (alcoholic beer) or Group B (nonalcoholic beer). Study beverages will need to be consumed within 30 minutes post-race. Subjects needing to urinate during the study period (after they have started drinking study beverage) will be asked to provide urine output to assess urine volume and dipstick analysis.  Subjects in both groups will have their blood levels retested 60 minutes after commencement of drinking the study beverage.

During the 60 minute study period, subjects will be medically monitored for safety, will have urine output monitored and collected as previously stated, will complete a questionnaire on salt and water consumption during the race, and running experience, and will be asked to complete a clock-drawing test. Subjects will be asked not to consume any food or additional liquid at this time. Subjects will be provided with their sodium level results pre and post intervention along with an information card that will include implications of what their sodium level may mean.

Challenges

These endurance events are frequently held in remote locations with inherent challenges present to delivering standard prehospital medical care. Equipment and supplies at these events are frequently limited by weight and transportation concern. The need for experienced wilderness medical staff is essential to provide good medical care in these environments.

Subjects identified with hyponatremia will be observed closely for at least 60 minutes to determine mental status and other symptoms. For those subjects who have an initial sodium found to be < 130mEq/L, the race medical staff will explain the risks and offer to have a nurse place an intravenous line as a precaution that will be available for administration of treatment (3% saline) should the athlete become encephalopathic or exhibit any other symptoms requiring emergency medical treatment (the subject may decline). Hypertonic saline (3% saline) is the standard of care treatment for EAH encephalopathy. If after the second blood draw the subject is found to be hyponatremic, they will continue to be observed by a medical professional.

Subjects that vomit during the study period will immediately be evaluated by the race medical staff. It will be at the medical staff’s discretion to determine subjects’ ability to continue in the study.  If they are medically cleared to continue, they will be given Zofran and if no vomiting persists after 5 minutes they will be allowed to continue consumption of the study beverage. If medical staff determine that it is unsafe for the subject to continue they will be withdrawn from the study and released to the care of the medical staff.

Pre Analysis Plan

All data will be analyzed as intention to treat.  Demographic and baseline data will be analyzed to determine homogeneity of treatment groups. Primary analysis will be conducted to determine if treatment group significantly impacted subject’s sodium level, most importantly to the group of subjects with an immediate post-race sodium < 135mEq/L. In addition, we would like to determine if administration of the clock drawing test can accurately identify subjects with an immediate post-race sodium < 135mEq/L. Other blood and urine values will be used to determine if other factors may play a role in determining subject risk for post-race low sodium levels or in post-race change in sodium level.