An interventional study of High oral Fructose challenge (150g per day for 28 days) in Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-28.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention
The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and treatment options are limited. Fructose overconsumption has been associated with gut permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis of intestinal biopsies. Findings in volunteers will be compared with liver patients undergoing study procedures without fructose challenge. Translational in vitro experiments will explore cellular responses to fructose and endotoxin. This project should provide novel insights into dietary induced alterations of the gut integrity in progression of NAFLD to NASH.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Signed informed consent
General exclusion criteria (for all groups)
Volunteers will be challenged with oral 150g Fructose per day for 28 days.
Dietary Supplement: High oral Fructose challenge (150g per day for 28 days)
Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.
Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.
Patients with confirmed hepatitis C genotype 1 will be compared at baseline with other arms and act as different liver disease control group
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only
Time frame: Time point 1 (day 1 - all study groups)
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
Gaps per 1000 intestinal cells will be assesed during gastroscopy by confocal laser endomicroscopy at time point 1 in all study groups and after the 4 week fructose challange in healthy volunteers only
Time frame: point 2 (week4/day28 - after fructose challange; healthy volunteers only)
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
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