Binge DrinkingNCT02568904
Alcohol and Innate Immunity
An observational study of Binge Drinking, run by Medical University of Graz at 1 site in Austria.
Trial summary
Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to inflammation and immune dysfunction as well as the typical hangover symptoms. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking
- What is being tested?
- Alcohol, Glucose and Fructose
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2016to 22 Feb 2019
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers selected from a database
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Age above 18 years
- Willingness to abstain from alcohol 48h prior to the study visits
Who cannot join
- Alcohol abuse .Alcohol Use Disorders Identification Test ≥ 8 in men or ≥ 7 in women or CAGE test ≥ 2 (both men and women)
- Elevated liver function test
- Any disease or medication that does not allow concomitant consumption of alcohol
- Women: pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine, Medical University of Graz
Graz, 8010
About this study
Official title: The Effects of Binge Drinking on Innate Host Defence Mechanisms
Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to inflammation and immune dysfunction as well as the typical hangover symptoms.
Read the detailed description
Alcohol binge drinking, defined as 5 or more drinks for men and 4 or more drinks for women at one time, is the most frequent form of alcohol consumption worldwide, especially in younger people. This drinking pattern is popular and leads to increased mortality and morbidity. Therefore binge drinking is a major public health issue. The behavioural and neurological consequences of binge drinking are well characterized.
Less is known about the systemic effects on the gut as the first organ in contact with alcohol. Chronic alcohol intake can lead to increased gut permeability, bacterial translocation and alterations in the gut microbiome in animal models. Recently bacterial translocation has been shown in healthy volunteers after a single alcohol binge. On immune cells, acute alcohol intake seems to have dichotomous effects. On the one hand immunosuppressive and anti-inflammatory effects have been described, however, alcohol induced liver injury is driven by pro-inflammatory reactions. These immune effects seem to be driven by endotoxin or other bacterial products via Toll-like receptors that are translocated to the circulation via a defective gut barrier. Immune effects of alcohol have also been linked to hangover symptoms after an alcohol binge.
Furthermore there is evidence that endotoxemia might also contributes to alcohol dependence by promoting prolonged and increased voluntary alcohol intake in mice. On the other hand mutant mice lacking important genes for immune responses exhibit decreased alcohol consumption. This indicates that immune signaling promotes alcohol consumption. Therefore it is tempting to speculate that increased gut permeability leading to increased bacterial translocation after an acute alcohol binge could promote the desire for further alcohol consumption.
The investigators aim to test in this pilot trial whether one alcohol binge damages gut barrier function, increases bacterial translocation and causes innate immune dysfunction. Furthermore the effect of glucose and fructose will be studied too.
- Conditions
- Binge Drinking
- Being tested
- Alcohol, Glucose, Fructose, vehicle
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
every participant will drink vodka at a dose of 2ml/kg bodyweight
GlucoseOther
oral Glucose tolerance test
FructoseOther
oral fructose tolerance test
vehicleOther
control (water)
| Study group | Role | What they receive |
|---|---|---|
| Alcohol binge | Healthy volunteers receive 2ml vodka 40% per kg bodyweight as a binge Receives: Other: Alcohol | |
| Fructose | 75 g Fructose orally Receives: Other: Fructose | |
| Glucose | 75 g Glucose orally Receives: Other: Glucose | |
| Vehicle | 2ml tap water per kg body weight Receives: Other: vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin assessed by percentage of endotoxin positive subjects
Endotoxin measured by a HEK-blue cell based assay
Measured: 4 hours
Secondary outcomes (7)
gut permeability (zonulin in stool)
changes in gut permeability
Measured: 4 hours
bacterial translocation (bacterial DNA in serum)
changes in bacterial translocation
Measured: 4 hours
oxidative stress (advanced oxidation protein products)
changes in oxidative stress
Measured: 4 hours
inflammation (neutrophil oxidative burst)
changes in inflammation
Measured: 4 hours
neutrophil phagocytic capacity
changes in neutrophil function
Measured: 4 hours
gut microbiome composition
changes in gut microbiome composition
Measured: 4 hours
fibroblast growth factor 21 (FGF21)
changes in FGF21 serum levels
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startDec 2016
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Stadlbauer, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568904
- Sponsor's protocol ID
- Alcohol01
- Status last verified
- May 2020
- First submitted
- 29 Jul 2015
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Binge Drinking on Innate Host Defence Mechanisms
- ClinicalTrials.gov ID
- NCT02568904
- Acronym / sponsor ID
- Alcohol01
- Conditions
- Binge Drinking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 6 Oct 2015 (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.
Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to inflammation and immune dysfunction as well as the typical hangover symptoms.
Detailed description
Alcohol binge drinking, defined as 5 or more drinks for men and 4 or more drinks for women at one time, is the most frequent form of alcohol consumption worldwide, especially in younger people. This drinking pattern is popular and leads to increased mortality and morbidity. Therefore binge drinking is a major public health issue. The behavioural and neurological consequences of binge drinking are well characterized.
Less is known about the systemic effects on the gut as the first organ in contact with alcohol. Chronic alcohol intake can lead to increased gut permeability, bacterial translocation and alterations in the gut microbiome in animal models. Recently bacterial translocation has been shown in healthy volunteers after a single alcohol binge. On immune cells, acute alcohol intake seems to have dichotomous effects. On the one hand immunosuppressive and anti-inflammatory effects have been described, however, alcohol induced liver injury is driven by pro-inflammatory reactions. These immune effects seem to be driven by endotoxin or other bacterial products via Toll-like receptors that are translocated to the circulation via a defective gut barrier. Immune effects of alcohol have also been linked to hangover symptoms after an alcohol binge.
Furthermore there is evidence that endotoxemia might also contributes to alcohol dependence by promoting prolonged and increased voluntary alcohol intake in mice. On the other hand mutant mice lacking important genes for immune responses exhibit decreased alcohol consumption. This indicates that immune signaling promotes alcohol consumption. Therefore it is tempting to speculate that increased gut permeability leading to increased bacterial translocation after an acute alcohol binge could promote the desire for further alcohol consumption.
The investigators aim to test in this pilot trial whether one alcohol binge damages gut barrier function, increases bacterial translocation and causes innate immune dysfunction. Furthermore the effect of glucose and fructose will be studied too.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol binge | – | Other: AlcoholHealthy volunteers receive 2ml vodka 40% per kg bodyweight as a binge |
| Fructose | – | Other: Fructose75 g Fructose orally |
| Glucose | – | Other: Glucose75 g Glucose orally |
| Vehicle | – | Other: vehicle2ml tap water per kg body weight |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers selected from a database
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Age above 18 years
- Willingness to abstain from alcohol 48h prior to the study visits
Key exclusion criteria (4 listed)
- Alcohol abuse .Alcohol Use Disorders Identification Test ≥ 8 in men or ≥ 7 in women or CAGE test ≥ 2 (both men and women)
- Elevated liver function test
- Any disease or medication that does not allow concomitant consumption of alcohol
- Women: pregnancy and lactation
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 |
|---|---|---|
| Alcoholevery participant will drink vodka at a dose of 2ml/kg bodyweight | Other | Alcohol binge |
| Glucoseoral Glucose tolerance test | Other | Glucose |
| Fructoseoral fructose tolerance test | Other | Fructose |
| vehiclecontrol (water) | Other | Vehicle |
Primary outcome
Endotoxin assessed by percentage of endotoxin positive subjects
Time frame: 4 hours
Endotoxin measured by a HEK-blue cell based assay
7 secondary outcomes
gut permeability (zonulin in stool)
Time frame: 4 hours
bacterial translocation (bacterial DNA in serum)
Time frame: 4 hours
oxidative stress (advanced oxidation protein products)
Time frame: 4 hours
inflammation (neutrophil oxidative burst)
Time frame: 4 hours
neutrophil phagocytic capacity
Time frame: 4 hours
gut microbiome composition
Time frame: 4 hours
fibroblast growth factor 21 (FGF21)
Time frame: 4 hours
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 15 May 2020.
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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.
Vanessa Stadlbauer, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binge Drinking, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 4 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 15 May 2020. 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 Austria. 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. 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?
Endotoxin assessed by percentage of endotoxin positive subjects (time frame: 4 hours). 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 15 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.