NCT02568904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

July 29, 2015

Last Update Submit

May 14, 2020

Conditions

Binge Drinking

Outcome Measures

Primary Outcomes (1)

  • Endotoxin assessed by percentage of endotoxin positive subjects

    Endotoxin measured by a HEK-blue cell based assay

    4 hours

Secondary Outcomes (7)

  • gut permeability (zonulin in stool)

    4 hours

  • bacterial translocation (bacterial DNA in serum)

    4 hours

  • oxidative stress (advanced oxidation protein products)

    4 hours

  • inflammation (neutrophil oxidative burst)

    4 hours

  • neutrophil phagocytic capacity

    4 hours

  • +2 more secondary outcomes

Study Arms (4)

Alcohol binge

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

Other: Alcohol

Fructose

75 g Fructose orally

Other: Fructose

Glucose

75 g Glucose orally

Other: Glucose

Vehicle

2ml tap water per kg body weight

Other: vehicle

Interventions

AlcoholOTHER

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

Alcohol binge
GlucoseOTHER

oral Glucose tolerance test

Glucose
FructoseOTHER

oral fructose tolerance test

Fructose
vehicleOTHER

control (water)

Vehicle

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers selected from a database

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Urine, Stool

MeSH Terms

Conditions

Binge Drinking

Interventions

EthanolGlucoseFructose

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Vanessa Stadlbauer, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

October 6, 2015

Study Start

December 1, 2016

Primary Completion

February 22, 2019

Study Completion

February 22, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

AU(1)