Effects of Ethanol on Gut Wall Integrity

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2012
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.
Epistemonikos ID: f90f5de70af743b24dd70a8e5fb2e88e228fa267
First added on: May 11, 2024