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| ID | Type | Description | Link |
|---|---|---|---|
| REC 08/H0403/14 | |||
| R&D 08GA001 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyunsaturated | Active Comparator | 5g per day of polyunsaturated fatty acids (3.5g EPA and DHA). |
|
| monounsaturated | Placebo Comparator | 5g a day of oleic enriched sunflower oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efamax | Dietary Supplement | 5g daily as capsules for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum liver function tests, lipids, free fatty acids | 3 months | |
| Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian A Macdonald, PhD | Biomedical Sciences, University Hospital, Nottingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson Digestive Diseases Centre, University Hospital | Nottingham | NG7 2UH | United Kingdom |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy |
| 3 months |
| Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin | 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 | 3 months |
| Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1 | 3 months |
| Compliance assessed by serum phospholipid fatty acids | 3 months |