An observational study in Binge Drinking, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Medical University of Graz · Observational
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.
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
Browse Binge Drinking studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers selected from a database
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers receive 2ml vodka 40% per kg bodyweight as a binge
Other: Alcohol
75 g Fructose orally
Other: Fructose
75 g Glucose orally
Other: Glucose
2ml tap water per kg body weight
Other: vehicle
every participant will drink vodka at a dose of 2ml/kg bodyweight
oral Glucose tolerance test
oral fructose tolerance test
control (water)
Endotoxin assessed by percentage of endotoxin positive subjects
Endotoxin measured by a HEK-blue cell based assay
Time frame: 4 hours
gut permeability (zonulin in stool)
changes in gut permeability
Time frame: 4 hours
bacterial translocation (bacterial DNA in serum)
changes in bacterial translocation
Time frame: 4 hours
oxidative stress (advanced oxidation protein products)
changes in oxidative stress
Time frame: 4 hours
inflammation (neutrophil oxidative burst)
changes in inflammation
Time frame: 4 hours
neutrophil phagocytic capacity
changes in neutrophil function
Time frame: 4 hours
gut microbiome composition
changes in gut microbiome composition
Time frame: 4 hours
fibroblast growth factor 21 (FGF21)
changes in FGF21 serum levels
Time frame: 4 hours
Ran from Dec 2016 to primary completion in Feb 2019, 26 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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