Beer for Endurance Exercise Recovery

NCT ID: NCT03032445

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-05-21

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 \[EAH\].

Detailed Description

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Conditions

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Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alcoholic beer

At least 6% alcohol content

Group Type EXPERIMENTAL

Alcoholic Beer

Intervention Type 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

Less than 0.5% alcohol content

Group Type PLACEBO_COMPARATOR

Non alcoholic beer

Intervention Type 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.

Interventions

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Alcoholic Beer

Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.

Intervention Type OTHER

Non 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.

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Joslin, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy Joslin, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Upstate Medicial University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Beer Trial

Identifier Type: -

Identifier Source: org_study_id

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