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Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477307
First Posted: November 22, 2011
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva
  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
Obesity Non-alcoholic Fatty Liver Disease (NAFLD) Other: Hypocaloric diet

Study Type: Observational
Study Design: Observational Model: Other
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 Prof. Claude Pichard, University Hospital, Geneva:

Primary Outcome Measures:
  • abundance of fecal abundance of fecal Bacteroidetes [ Time Frame: thrice, at inclusion, day 21 and day 42 ]
    Bacterial cells/g caecal content


Secondary Outcome Measures:
  • liver fat content [ Time Frame: twice, at inclusion and day 21 ]
    picsel/uni MRI

  • liver function tests [ Time Frame: four times, at screening, inclusion, day 21 and day 42 ]
    mmol/l

  • CRP [ Time Frame: thrice, at screening, inclusion and day 21 ]
    mg/l

  • serum cytokines [ Time Frame: twice, at inclusion and day 21 ]
    ng/ml

  • serum LPS [ Time Frame: twice, at inclusion and day 21 ]
    pg/ml

  • Breath test pullulation [ Time Frame: twice, at inclusion and day 21 ]
  • intestinal permeability [ Time Frame: twice, at inclusion and day 21 ]
    Polyethylene glycol 3350/Polyethylene glycol 400 ratio

  • body composition [ Time Frame: thrice, at inclusion, day 21 and day 42 ]
    body composition in kg and % of body weight

  • liver lipid composition (biopsy) [ Time Frame: once, at screening ]

Enrollment: 20
Actual Study Start Date: July 1, 2013
Study Completion Date: September 15, 2016
Primary Completion Date: August 31, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477307


Locations
Switzerland
Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Claude Pichard, MD Geneva University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Claude Pichard, Head, Clinical Nutrition, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01477307     History of Changes
Other Study ID Numbers: 10-231
First Submitted: November 15, 2011
First Posted: November 22, 2011
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Prof. Claude Pichard, University Hospital, Geneva:
obesity
non-alcoholic fatty liver disease

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases