Healthy Clinical Trial
Official title:
Identifying the Profile of the Main Non-oxidative Biomarkers of Alcohol (Ethyl Glucuronide, Ethyl Sulphate, Fatty Acid Ethyl Esters) After the Experimental Exposure to Increasing Doses of Alcohol in Adults.
The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of increasing doses of alcohol in adult subjects.
The abuse of alcohol causes serious health and social problems. Alcohol consumption can be
monitored by detecting biomarkers. In current practice indirect biomarkers (mean corpuscular
volume, transaminases, gammaglutamyl or carbohydrate-deficient transferrin) are used,
although direct biomarkers of alcohol, including alcohol itself and metabolites also exist.
Biomarkers of alcohol consumption are used as tools to prevent health and social problems
related with alcohol, allowing the identification of subjects at risk of abuse, dependence
or withdrawal and to assess the efficacy of treatments for alcohol dependence.
Non-oxidative metabolites (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters)
have longer biological half-life than ethanol and accumulate in tissues after consumption.
The objective of the study is to study the profile of ethanol and non-oxidative biomarkers
(ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental
administration of increasing doses of alcohol in adult subjects.
Subjects will be genotyped for genetic polymorphisms of proteins related to ethanol
metabolism and effects (as alcohol dehydrogenase and aldehyde dehydrogenase), and the
genotypes will be used to evaluate their influence in the results.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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