NCT02311686

Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Alcohol Consumption
• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	10 g ethanol	Alcohol single oral dose
DIETARY_SUPPLEMENT	20 g ethanol	Alcohol single oral dose
DIETARY_SUPPLEMENT	40 g ethanol	Alcohol single oral dose
DIETARY_SUPPLEMENT	60 g ethanol	Alcohol single oral dose
DIETARY_SUPPLEMENT	80 g ethanol	Alcohol single oral dose

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-12-08
• Last updated: 2016-05-16

Locations

1 site across 1 country: Spain