Trial record 15 of 138 for:
Open Studies | "Fatty Liver"
Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Geneva
Sponsor:
University Hospital, Geneva
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01477307
First received: November 15, 2011
Last updated: January 22, 2013
Last verified: January 2013
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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: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (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 22, 2013 |
| 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 May 16, 2013