Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver

This study is currently recruiting participants.
Verified January 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01477307
First received: November 15, 2011
Last updated: January 1, 2014
Last verified: January 2014
  Purpose

In patients with NAFLD/NASH, changes in liver lipid composition and function tests following a short dietary intervention are associated with changes in gut microbiota


Condition Intervention Phase
Obesity
Non-alcoholic Fatty Liver Disease (NAFLD)
Other: Hypocaloric diet
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Dietary Intervention on Intestinal Microbiota in Patients With Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • abundance of fecal abundance of fecal Bacteroidetes [ Time Frame: thrice, at inclusion, day 21 and day 42 ] [ Designated as safety issue: No ]
    Bacterial cells/g caecal content


Secondary Outcome Measures:
  • liver fat content [ Time Frame: twice, at inclusion and day 21 ] [ Designated as safety issue: No ]
    picsel/uni MRI

  • liver function tests [ Time Frame: four times, at screening, inclusion, day 21 and day 42 ] [ Designated as safety issue: No ]
    mmol/l

  • CRP [ Time Frame: thrice, at screening, inclusion and day 21 ] [ Designated as safety issue: No ]
    mg/l

  • serum cytokines [ Time Frame: twice, at inclusion and day 21 ] [ Designated as safety issue: No ]
    ng/ml

  • serum LPS [ Time Frame: twice, at inclusion and day 21 ] [ Designated as safety issue: No ]
    pg/ml

  • Breath test pullulation [ Time Frame: twice, at inclusion and day 21 ] [ Designated as safety issue: No ]
  • intestinal permeability [ Time Frame: twice, at inclusion and day 21 ] [ Designated as safety issue: No ]
    Polyethylene glycol 3350/Polyethylene glycol 400 ratio

  • body composition [ Time Frame: thrice, at inclusion, day 21 and day 42 ] [ Designated as safety issue: No ]
    body composition in kg and % of body weight

  • liver lipid composition (biopsy) [ Time Frame: once, at screening ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hypocaloric diet
The included patients are assigned to a hypocaloric standardized diet for 3 weeks.
Other: Hypocaloric diet
Eurodiet,standardized hypo-caloric diet, during 3 weeks
Other Name: eurodiet 2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obesity defined as BMI>30 Abnormal liver function tests defined as ALT > 1.5 times the upper limit of normal NAFLD present at liver biopsy Age > 18 years, < 60 years

Criteria

Inclusion Criteria:

Obesity defined as BMI>30 Abnormal liver function tests defined as ALT > 1.5 times the upper limit of normal NAFLD present at liver biopsy Age > 18 years, < 60 years

Exclusion Criteria:

Inability or unwillingness to give consent Bulimia Other known cause of chronic liver disease, including hepatitis B or C, iron overload, Use of substances known to alter intestinal permeability, including alcohol and NSAIDs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477307

Contacts
Contact: Claude Pichard, MD,PhD +41 22 37 29 349 claude.pichard@unige.ch
Contact: Zoltan Patakay, MD +41 79 58 290 Zoltan.Pataky@hcuge.ch

Locations
Switzerland
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Claude Pichard, MD    +41 22 37 29 349    claude.pichard@unige.ch   
Contact: Alain Golay, MD    +41 22 372 97 04    Alain.Golay@hcuge.ch   
Principal Investigator: Claude Pichard, MD         
Sub-Investigator: Antoine Hadengue, MD         
Sub-Investigator: Jacques Schrenzel, MD         
Sub-Investigator: Sylvain Terraz, MD         
Sub-Investigator: Alain Golay, MD         
Sub-Investigator: Laura Rubbia-Brandt, MD         
Sub-Investigator: Vladimir Lazarevic, MD         
Sub-Investigator: Laurence Genton, MD         
Sub-Investigator: Zoltan Patakay, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Claude Pichard, MD Geneva University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Claude Pichard, Head, Clinical Nutrition, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01477307     History of Changes
Other Study ID Numbers: 10-231
Study First Received: November 15, 2011
Last Updated: January 1, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
obesity
non-alcoholic fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Obesity
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014