HyponatremiaBEERNCT03032445
Beer for Endurance Exercise Recovery
A study testing Alcoholic Beer and Non alcoholic beer in people with Hyponatremia, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Alcoholic Beer and Non alcoholic beer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 21 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Potential Impacts of Beer on Post-Race Ultramarathon Athletes
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
- Being tested
- Alcoholic Beer, Non alcoholic beer
- Keywords
- Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic BeerOther
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 beerOther
Subject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic beer | Experimental | At least 6% alcohol content Receives: Other: Alcoholic Beer |
| Non alcoholic beer | Placebo comparator | Less than 0.5% alcohol content Receives: Other: Non alcoholic beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sodium level pre and post intervention
Measured: One hour
Secondary outcomes (3)
Measurement of urine output
Measured: One hour
Number of participants with abnormal laboratory values
Measured: One hour
Level of cognition
Cognitive level determined by assessment of clock drawing test.
Measured: Within one month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion21 May 2017
- Study completion21 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Joslin, MD, State University of New York - Upstate Medical University
- Investigators
- Jeremy Joslin, MD, Principal investigator, SUNY Upstate Medicial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032445
- Sponsor's protocol ID
- Beer Trial
- Acronym
- BEER
- Status last verified
- Apr 2018
- First submitted
- 12 Jan 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Impacts of Beer on Post-Race Ultramarathon Athletes
- ClinicalTrials.gov ID
- NCT03032445
- Acronym / sponsor ID
- BEER / Beer Trial
- Conditions
- Hyponatremia
- Keywords
- Body Water/physiology, Hyponatremia/etiology, Physical Exertion/physiology, Running/physiology, Sodium/blood, Ethanol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 21 May 2017 (actual)
- Study completion
- 21 May 2017 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic beer | Experimental | Other: Alcoholic BeerAt least 6% alcohol content |
| Non alcoholic beer | Placebo comparator | Other: Non alcoholic beerLess than 0.5% alcohol content |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholic BeerSubject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage. | Other | Alcoholic beer |
| Non alcoholic beerSubject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage. | Other | Non alcoholic beer |
Primary outcome
Changes in sodium level pre and post intervention
Time frame: One hour
3 secondary outcomes
Measurement of urine output
Time frame: One hour
Number of participants with abnormal laboratory values
Time frame: One hour
Level of cognition
Time frame: Within one month of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Hyponatremia
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Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
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Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Thiazide Associated Hyponatremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Joslin, MD principal investigator
SUNY Upstate Medicial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcoholic Beer and Non alcoholic beer in people with Hyponatremia, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sodium level pre and post intervention (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.