Status:

COMPLETED

Effects of Ethanol on Intestinal Permeability and Integrity

Lead Sponsor:

Maastricht University Medical Center

Collaborating Sponsors:

Top Institute Food and Nutrition

Conditions:

Healthy

Eligibility:

MALE

18-45 years

Phase:

NA

Brief Summary

Alcohol consumption is a major health problem worldwide. It affects all systems of the body especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious effects on the g...

Eligibility Criteria

Inclusion

  • Signed informed consent form.
  • Male gender to avoid the gender-related differences in ethanol metabolism.
  • Between 18-45 years to avoid age-related changes in ethanol metabolism39.
  • Normal medical history and physical examination.
  • Normal liver function tests (i.e. ALT, AST, and γGT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University Medical Center.
  • Caucasian ethnicity.
  • BMI=18 - 30 kg/m2.

Exclusion

  • History of gastro-intestinal disorders or abdominal surgery.
  • History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)40.
  • Recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., NSAIDs, benzodiazepines and antidepressants.
  • Smoking.

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT00928733

Start Date

September 1 2009

End Date

January 1 2012

Last Update

November 13 2014

Active Locations (1)

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands, 6202 AZ