Dietary Intervention and Intestinal Microbiota in Non-alcoholic Fatty Liver

NCT01477307 | Completed DMC

• 1 other identifier: 10-231
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

obesity; non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• abundance of fecal abundance of fecal Bacteroidetes

  Bacterial cells/g caecal content

  thrice, at inclusion, day 21 and day 42

Secondary Outcomes (9)

• liver fat content

  twice, at inclusion and day 21

• liver function tests

  four times, at screening, inclusion, day 21 and day 42

• CRP

  thrice, at screening, inclusion and day 21

• serum cytokines

  twice, at inclusion and day 21

• serum LPS

  twice, at inclusion and day 21

Study Arms (1)

hypocaloric diet

The included patients are assigned to a hypocaloric standardized diet for 3 weeks.

Other: Hypocaloric diet

Interventions

Hypocaloric diet OTHER

Eurodiet,standardized hypo-caloric diet, during 3 weeks

Also known as: eurodiet 2

hypocaloric diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27142672 DERIVED

Related Links

• Geneva university hospital

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Claude Pichard, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Clinical Nutrition

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: July 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: September 15, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CH (1)