Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver
NCT ID: NCT01477307
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2013-07-01
2016-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study period:
* Study duration for the participant: 7-10 weeks (1-4 weeks screening period, 3 weeks of intervention + 3 weeks of follow-up)
* Expected study completion date: 30.04.2012 Study type: Single arm before-after study
Number of patients:
20 subjects with obesity and NAFLD / NASH
Main criteria for inclusion:
* 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
Main exclusion criteria:
* Inability or unwillingness to give consent
* Parenteral nutrition or other ongoing dietary intervention
* 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
Intervention:
The phase 2 Eurodiet® program will be used as standardized hypo-caloric diet during a 3-weeks intervention period. The products are commercially available and prescribed to reach 1000 kcal/day. These products will be offered free of charge.
Primary Objective:
To assess the impact of dietary intervention on the relative abundance of fecal Bacteroidetes (expressed as the bacteroidetes to firmicutes ratio) in patients with obesity, abnormal liver function tests and NAFLD
Secondary Objectives:
1. To compare fecal microbiota from patients with NAFLD or NASH at baseline
2. To assess fecal microbiota changes in patients with NAFLD or NASH after dietary intervention
3. To measure liver fat content at baseline and after dietary intervention
4. To assess changes in liver function tests and ultrasensitive CRP, cytokines and serum LPS in relation to changes in microbiota and liver lipid composition
5. To measure orocecal transit time, an index of intestinal pullulation, at baseline and after dietary intervention in patients with NAFLD or NASH
6. To measure intestinal permeability at baseline and after dietary intervention in patients with NAFLD or NASH
7. To assess body composition changes in relation to changes in microbiota and liver lipid composition
Statistical methods:
Baseline and end-of-treatment changes for both bacterial genders and subspecies will be compared using paired-sample Wilcoxon signed-rank test. ANOVA and paired t-test for comparison of other changes within groups. Pearson or Spearman tests will be used to assess correlations between changes in microbiota and changes in liver fat content, liver function tests, CRP, cytokines and intestinal pullulation and permeability.
Sample size:
20 patients with NAFLD/NASH will be studied before and after dietary intervention.
Assessment of end-points:
Fecal microbiota will be analysed with 454-Flex metagenomics Ultrasensitive CRP and serum LPS changes as compared with baseline Serum cytokines as measured with ELISA Liver fat content and composition will be measured using MR spectroscopy Small intestinal overgrowth and intestinal permeability will be assessed using standard 13C breath tests and polyethyleneglycol absorption test Body mass composition changes will be assessed using bioelectrical impedance analysis
Safety :
All adverse events will be recorded throughout the study, in compliance with GCP ICH E6 and national regulations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
hypocaloric diet
The included patients are assigned to a hypocaloric standardized diet for 3 weeks.
Hypocaloric diet
Eurodiet,standardized hypo-caloric diet, during 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypocaloric diet
Eurodiet,standardized hypo-caloric diet, during 3 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Geneva
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Claude Pichard
Head, Clinical Nutrition
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claude Pichard, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Geneva University Hospital
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pataky Z, Genton L, Spahr L, Lazarevic V, Terraz S, Gaia N, Rubbia-Brandt L, Golay A, Schrenzel J, Pichard C. Impact of Hypocaloric Hyperproteic Diet on Gut Microbiota in Overweight or Obese Patients with Nonalcoholic Fatty Liver Disease: A Pilot Study. Dig Dis Sci. 2016 Sep;61(9):2721-31. doi: 10.1007/s10620-016-4179-1. Epub 2016 May 3.
Related Links
Access external resources that provide additional context or updates about the study.
Geneva university hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-231
Identifier Type: -
Identifier Source: org_study_id