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Beer for Endurance Exercise Recovery (BEER)

Primary Purpose

Hyponatremia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcoholic Beer
Non alcoholic beer
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Upstate Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alcoholic beer

Non alcoholic beer

Arm Description

At least 6% alcohol content

Less than 0.5% alcohol content

Outcomes

Primary Outcome Measures

Changes in sodium level pre and post intervention

Secondary Outcome Measures

Measurement of urine output
Number of participants with abnormal laboratory values
Level of cognition
Cognitive level determined by assessment of clock drawing test.

Full Information

First Posted
January 12, 2017
Last Updated
April 25, 2018
Sponsor
State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03032445
Brief Title
Beer for Endurance Exercise Recovery
Acronym
BEER
Official Title
Potential Impacts of Beer on Post-Race Ultramarathon Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 21, 2017 (Actual)
Study Completion Date
May 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcoholic beer
Arm Type
Experimental
Arm Description
At least 6% alcohol content
Arm Title
Non alcoholic beer
Arm Type
Placebo Comparator
Arm Description
Less than 0.5% alcohol content
Intervention Type
Other
Intervention Name(s)
Alcoholic Beer
Intervention Description
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
Intervention Name(s)
Non alcoholic beer
Intervention Description
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 Outcome Measure Information:
Title
Changes in sodium level pre and post intervention
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Measurement of urine output
Time Frame
One hour
Title
Number of participants with abnormal laboratory values
Time Frame
One hour
Title
Level of cognition
Description
Cognitive level determined by assessment of clock drawing test.
Time Frame
Within one month of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Joslin, MD
Organizational Affiliation
SUNY Upstate Medicial University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Beer for Endurance Exercise Recovery

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