Obesity Clinical Trial
Official title:
Effect of Dietary Intervention on Intestinal Microbiota in Patients With Non-alcoholic Fatty Liver Disease
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
Study Hypothesis: 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
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.
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