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OpenTrials
Completed

NCT Number: NCT03032445

Beer for Endurance Exercise Recovery

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].

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcoholic Beer

Other

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

Other

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 outcomes

  1. Changes in sodium level pre and post intervention

    Time frame: One hour

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study title

Potential Impacts of Beer on Post-Race Ultramarathon Athletes

Acronym: BEER

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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