NCT02126072

Brief Summary

Objective: To determine the immediate effects of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by I-FABP and LBP. Study design: Randomized, single blinded cross over study. Study population: 15 healthy adult male human volunteers will be included in this study. Intervention: the consumption of alcoholic beverages (1 g/kg ethanol) of wine (12%) compared to the consumption of water. Main study parameters/endpoints: The aim of this study is to determine the immediate effects of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by I-FABP and LBP. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects consume 1g of alcohol per kg bodyweight. One blood sample of 14 ml followed by 6 samples of 8 ml will be drawn between 16.45 hours and 19:00 hours the day after. The first 6 observations take place in a single visit followed by one observation in short visit the next day. It is unlikely that subjects will experience any physical or psychological discomfort from the withdrawal of a total of 62 ml of blood in 24 hours or the consumption of the amounts alcohol or water mentioned above. The same protocol will be repeated one week after the first visit in which the alcohol group and water group are crossed over.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

April 23, 2014

Last Update Submit

April 25, 2014

Conditions

Alcohol Consumption

Keywords

EthanolAlcoholConsumptionGut wall integrityEndotoxemia

Outcome Measures

Primary Outcomes (1)

  • The immediate effects of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by I-FABP, LBP and IL-6.

    The hours after consumption until 24 hours post-consumption

Secondary Outcomes (1)

  • The immediate effects of oral alcohol consumption in healthy volunteers on the hepatocyte as measured by L-FABP, AST, ALT and GGT.

    The hours after consumption until 24 hours post-consumption.

Study Arms (2)

Alcohol

EXPERIMENTAL

The study is a randomized single blinded trial in cross over design. Subjects are randomized to drink alcohol in one session and water in another session.

Dietary Supplement: Alcohol

Water

ACTIVE COMPARATOR

Water in the same volume as the volunteer would have to drink in wine according to the protocol.

Dietary Supplement: Water

Interventions

AlcoholDIETARY_SUPPLEMENT

They consume 1gram of alcohol per kilogram of bodyweight in wine (12%)

Alcohol
WaterDIETARY_SUPPLEMENT

Volunteers consume the same volume of water as the would in wine according toe the protocol.

Water

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male volunteers
  • age between 18 and 60 years
  • written informed consent

You may not qualify if:

  • medical history of alcohol abuse
  • use of any medication
  • medical history of bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 VB, Netherlands

Location

MeSH Terms

Conditions

Alcohol DrinkingEndotoxemia

Interventions

EthanolWater

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 29, 2014

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

March 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

NL(1)