Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis
• Interventions: Dietary Supplement: High oral Fructose challenge (150g per day for 28 days)

• Registration Number: NCT01696487
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-09-01
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-01
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	High oral Fructose challenge (150g per day for 28 days)	Volunteers will be challenged with oral 150g Fructose per day for 28 days.

Primary Outcome Measures

Name	Time	Method
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy	point 2 (week4/day28 - after fructose challange; healthy volunteers only)	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

Trial Locations

Locations (1)

Medical University of Vienna, General Hospital of Vienna; 🇦🇹 Vienna, Austria