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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Johnston, University of Nottingham
ClinicalTrials.gov Identifier:
NCT00819338
First received: January 8, 2009
Last updated: July 3, 2012
Last verified: July 2012

January 8, 2009
July 3, 2012
January 2009
March 2010   (final data collection date for primary outcome measure)
Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819338 on ClinicalTrials.gov Archive Site
  • Serum liver function tests, lipids, free fatty acids [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Compliance assessed by serum phospholipid fatty acids [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in plasma biochemistry, insulin resistance, lipids, inflammatory cytokines [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • change in liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • changes in blood pressure, abdominal obesity and anthropometry as assessed clinically and by MR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • changes in diet as assessed historically [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease
The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-alcoholic Fatty Liver Disease
Dietary Supplement: Efamax
5g daily as capsules for 3 months
Other Names:
  • efamax
  • oleic enriched sunflower oil
  • Active Comparator: polyunsaturated
    5g per day of polyunsaturated fatty acids (3.5g EPA and DHA).
    Intervention: Dietary Supplement: Efamax
  • Placebo Comparator: monounsaturated
    5g a day of oleic enriched sunflower oil
    Intervention: Dietary Supplement: Efamax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00819338
NottinghamNHST1, REC 08/H0403/14, R&D 08GA001
No
Richard Johnston, University of Nottingham
University of Nottingham
Not Provided
Study Chair: Ian A Macdonald, PhD Biomedical Sciences, University Hospital, Nottingham
University of Nottingham
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP