Completed

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

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What is being tested

High oral Fructose challenge (150g per day for 28 days)

Dietary Supplement
Who is being recruted

Digestive System Diseases+1

+ Fatty Liver

+ Liver Diseases

From 18 to 85 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorMedical University of Vienna
Last updated: September 28, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01696487
Principal SponsorMedical University of Vienna
Last updated: September 28, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFatty LiverLiver DiseasesNon-alcoholic Fatty Liver Disease

Criteria

12 exclusion criteria prevent from participating
Alcoholic steatohepatitis and/or alcohol consumption > 140 gramms per week (or > 30g/day)
General and absolute endoscopy contraindications
Imprisoned persons
Inability or contraindications to perform study procedures
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Volunteers will be challenged with oral 150g Fructose per day for 28 days.

Group II

No Intervention
Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms.

Group III

No Intervention
Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms.

Group IV

No Intervention
Patients with confirmed hepatitis C genotype 1 will be compared at baseline with other arms and act as different liver disease control group

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of Vienna, General Hospital of Vienna

Vienna, AustriaOpen Medical University of Vienna, General Hospital of Vienna in Google Maps
CompletedOne Study Center