Status:
COMPLETED
The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease
Lead Sponsor:
University of Nottingham
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-alcoho...
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 ...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Liver biopsy diagnosis of NAFLD
Exclusion
- Excessive alcohol intake - \> 21 units per week in men and \> 14 in women
- A further liver disease diagnosis
- Poorly controlled diabetes - HbA1c \> 8.0%, or use of insulin sensitisers
- Pregnancy
- Cirrhosis
- Contraindications to MR scanning - pacemaker or metallic foreign body etc.
- Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
- Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
- Significant co-morbid inflammatory illnesses as determined by research team
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00819338
Start Date
January 1 2009
End Date
March 1 2010
Last Update
July 4 2012
Active Locations (1)
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1
Wolfson Digestive Diseases Centre, University Hospital
Nottingham, United Kingdom, NG7 2UH