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The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819338
First Posted: January 9, 2009
Last Update Posted: July 4, 2012
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):
Richard Johnston, University of Nottingham
  Purpose
The principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease.

Condition Intervention Phase
Non-alcoholic Fatty Liver Disease Dietary Supplement: Efamax Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Richard Johnston, University of Nottingham:

Primary Outcome Measures:
  • Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Serum liver function tests, lipids, free fatty acids [ Time Frame: 3 months ]
  • Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index [ Time Frame: 3 months ]
  • Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy [ Time Frame: 3 months ]
  • Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin [ Time Frame: 3 months ]
  • Primary assessment of the fibrotic and inflammatory status of the liver with serum TGF beta, TNF a, IL-6, IL-8, IL-8, IL-10 [ Time Frame: 3 months ]
  • Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1 [ Time Frame: 3 months ]
  • Compliance assessed by serum phospholipid fatty acids [ Time Frame: 3 months ]

Enrollment: 58
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: polyunsaturated
5g per day of polyunsaturated fatty acids (3.5g EPA and DHA).
Dietary Supplement: Efamax
5g daily as capsules for 3 months
Other Name: oleic enriched sunflower oil
Placebo Comparator: monounsaturated
5g a day of oleic enriched sunflower oil
Dietary Supplement: Efamax
5g daily as capsules for 3 months
Other Name: oleic enriched sunflower oil

Detailed Description:

Non-alcoholic fatty liver disease (NAFLD) is present in 10-24% of the general adult population. The first step of NAFLD involves the accumulation of fat within the liver (steatosis). Steatosis occurs either due to defective generation, metabolism or excretion of fatty acids by the liver. The next step in NAFLD progression is inflammation, which commonly occurs due to pro-inflammatory stimuli. Persistent inflammation results in end-stage liver disease. NAFLD is associated with the metabolic syndrome, which is characterised by central obesity, insulin resistance, raised triglycerides and hypertension. With the current obesity epidemic, there is predicted to be greater numbers of patients with NAFLD in the future.

Polyunsaturated fatty acids (PUFAs) are essential components of our diet, though standard Western intakes are lower than the recommended amounts. Supplementing the long chain n-3 PUFAs (commonly termed omega-3), EPA and DHA, improves many of the metabolic syndrome features. They lower plasma triglycerides, and may improve insulin resistance.

The diet of NAFLD patients tends to be deficient in n-3 PUFAs and have an excessive intake of the harmful n-6 PUFAs. This pattern is mirrored in their liver lipid content as assessed at biopsy.

Currently there is no proven treatment for NAFLD. Animal studies and limited studies in patients have been supportive of a benefit with n-3 polyunsaturated fatty acids. This needs to be further assessed.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 18 years
  2. Liver biopsy diagnosis of NAFLD

Exclusion Criteria:

  1. Excessive alcohol intake - > 21 units per week in men and > 14 in women
  2. A further liver disease diagnosis
  3. Poorly controlled diabetes - HbA1c > 8.0%, or use of insulin sensitisers
  4. Pregnancy
  5. Cirrhosis
  6. Contraindications to MR scanning - pacemaker or metallic foreign body etc.
  7. Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
  8. Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
  9. Significant co-morbid inflammatory illnesses as determined by research team
  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): NCT00819338


Locations
United Kingdom
Wolfson Digestive Diseases Centre, University Hospital
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Ian A Macdonald, PhD Biomedical Sciences, University Hospital, Nottingham
  More Information

Responsible Party: Richard Johnston, Doctor, University of Nottingham
ClinicalTrials.gov Identifier: NCT00819338     History of Changes
Other Study ID Numbers: NottinghamNHST1
REC 08/H0403/14
R&D 08GA001
First Submitted: January 8, 2009
First Posted: January 9, 2009
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by Richard Johnston, University of Nottingham:
Non-alcoholic fatty liver disease
Polyunsaturated fatty acids
Omega-3

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