Beer for Endurance Exercise Recovery

NCT03032445 | Completed

• 1 other identifier: Beer Trial
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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 \[EAH\].

Conditions

Hyponatremia

Keywords

Body Water/physiology; Hyponatremia/etiology; Physical Exertion/physiology; Running/physiology; Sodium/blood; Ethanol

Outcome Measures

Primary Outcomes (1)

• Changes in sodium level pre and post intervention

  One hour

Secondary Outcomes (3)

• Measurement of urine output

  One hour

• Number of participants with abnormal laboratory values

  One hour

• Level of cognition

  Within one month of intervention

Study Arms (2)

Alcoholic beer

EXPERIMENTAL

At least 6% alcohol content

Other: Alcoholic Beer

Non alcoholic beer

PLACEBO COMPARATOR

Less than 0.5% alcohol content

Other: Non alcoholic beer

Interventions

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.

Alcoholic beer

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.

Non alcoholic beer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeremy Joslin, MD

  SUNY Upstate Medicial University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 26, 2017
• Study Start: March 1, 2017
• Primary Completion: May 21, 2017
• Study Completion: May 21, 2017
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)