Alcohol and Innate Immunity

NCT ID: NCT02568904

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-02-22

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Alcohol binge

Healthy volunteers receive 2ml vodka 40% per kg bodyweight as a binge

Alcohol

Intervention Type: OTHER

every participant will drink vodka at a dose of 2ml/kg bodyweight

Fructose

75 g Fructose orally

Fructose

Intervention Type: OTHER

oral fructose tolerance test

Glucose

75 g Glucose orally

Glucose

Intervention Type: OTHER

oral Glucose tolerance test

Vehicle

2ml tap water per kg body weight

vehicle

Intervention Type: OTHER

control (water)

Interventions

Alcohol

every participant will drink vodka at a dose of 2ml/kg bodyweight

Intervention Type: OTHER

Glucose

oral Glucose tolerance test

Intervention Type: OTHER

Fructose

oral fructose tolerance test

Intervention Type: OTHER

vehicle

control (water)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Stadlbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Department of Internal Medicine, Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

Alcohol01

Identifier Type: -

Identifier Source: org_study_id