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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819338
• Other study ID #: NottinghamNHST1
• Secondary ID: REC 08/H0403/14R
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: July 3, 2012
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: July 2012
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Efamax
5g daily as capsules for 3 months

Locations

Country	Name	City	State
United Kingdom	Wolfson Digestive Diseases Centre, University Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy		3 months	No
Secondary	Serum liver function tests, lipids, free fatty acids		3 months	No
Secondary	Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index		3 months	No
Secondary	Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy		3 months	No
Secondary	Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin		3 months	No
Secondary	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		3 months	No
Secondary	Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1		3 months	No
Secondary	Compliance assessed by serum phospholipid fatty acids		3 months	No