Non-alcoholic Fatty Liver DiseaseNCT01696487
Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.
A study testing High oral Fructose challenge (150g per day for 28 days) in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- What is being tested?
- High oral Fructose challenge (150g per day for 28 days)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Healthy men and women from 18 to 85, no disease history, no intake of regular medication.
- Patients with confirmed (at least one imaging positive) intrahepatic fat accumulation (NAFL), male and female
- Patients with confirmed NASH (biopsy within 6 months prior to study), male and female
- Diagnosed HCV, genotype 1, male and female
Signed informed consent
General exclusion criteria (for all groups)
- Pregnancy and lactation
- Imprisoned persons
- Inflammatory bowel conditions (celiac disease, Crohn's disease, ulcerative colitis)
- Prior bariatric surgery
- Alcoholic steatohepatitis and/or alcohol consumption > 140 gramms per week (or > 30g/day)
- Other liver diseases (autoimmune, genetic, cholestatic, Wilson disease, Weber-Christian disease, partial lipodystrophy of the face sparing type, abetalipoproteinemia, and jejunal diverticulosis with bacterial overgrowth.)
- Virus hepatitis (A, B, C) (except for group (4): defined as HCV, genotype 1)
- Known allergic reaction to the drugs used (see material and methods)
- Intake of drugs known to accumulate intrahepatic lipids (e.g. steroids/glucocorticoids, tamoxifen, amiodarone, perhexiline maleate, synthetic estrogens, antiretroviral agents, tetracycline, minocycline, certain pesticides, methotrexate)
- Intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral contraceptive pills)
- Inability or contraindications to perform study procedures
- General and absolute endoscopy contraindications
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, General Hospital of Vienna
Vienna, 1090
About this study
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.
- Being tested
- High oral Fructose challenge (150g per day for 28 days)
- Keywords
- non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, NAFLD, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High oral Fructose challenge (150g per day for 28 days)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Volunteers will be challenged with oral 150g Fructose per day for 28 days. Receives: Dietary Supplement: High oral Fructose challenge (150g per day for 28 days) |
| NAFLD | No intervention | Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms. |
| NASH | No intervention | Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms. |
| Hepatitis C genotype 1 (HCV-GT1) | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: point 2 (week4/day28 - after fructose challange; healthy volunteers only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)
- Responsible party
- Principal investigator, Prof. Michael Trauner, MD, Medical University of Vienna
- Investigators
- Michael Trauner, MD, Principal investigator, Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696487
- Sponsor's protocol ID
- Fru1.0
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.
- ClinicalTrials.gov ID
- NCT01696487
- Acronym / sponsor ID
- Fru1.0
- Keywords
- non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, NAFLD, NASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- State Government of Vienna, Austria (Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Dietary Supplement: High oral Fructose challenge (150g per day for 28 days)Volunteers will be challenged with oral 150g Fructose per day for 28 days. |
| NAFLD | No intervention | –Patients with confirmed fatty liver (imaging positive) will be compared at baseline with other arms. |
| NASH | No intervention | –Patients with confirmed non-alcoholic steatohepatitis (biopsy proven) will be compared at baseline with other arms. |
| Hepatitis C genotype 1 (HCV-GT1) | 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High oral Fructose challenge (150g per day for 28 days) | Dietary supplement | Healthy Volunteers |
Primary outcome
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
Time frame: Time point 1 (day 1 - all study groups)
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
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Trauner, MD principal investigator
Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High oral Fructose challenge (150g per day for 28 days) in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gaps per 1000 intestinal epithelial cells assessed by confocal laser endomicroscopy (time frame: Time point 1 (day 1 - all study groups)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.