Polyunsaturated Fatty Acids in Patients With NAFLD.

Study Overview
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Brief Summary
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Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data, as well as parameters of liver steatosis and fibrosis will be tested.

Detailed Description
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Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data will be recorded and the following parameters will be tested: panel of biochemistry and liver function tests: triglycerides, cholesterol, HDLcholesterol, LDL-cholesterol, glucose, insulin, serum bilirubin, liver tests, thyroid hormones, bile acids and their metabolites, albumin, total protein. Bioactive metabolites, Inflammatory markers Non-invasive serum markers of liver fibrosis and steatohepatitis. Hyaluronic acid, NAFLD fibrosis score, cytokeratine-18 fragments. Ultrasonography with non-invasive measurement of fibrosis and steatosis, magnetic resonance spectroscopy for visceral and liver fat determination.

Official Title
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Nutrition-based Therapy of Liver Disease of Different Origin: Effect of n-3 Polyunsaturated Fatty Acid in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome.

Conditions
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NAFLD

Intervention / Treatment
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* Dietary Supplement: Maxicor
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with metabolic syndrome and NAFLD Exclusion Criteria: Age below 18 years Gravidity Incompliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyunsaturated omega-3 fatty acids<br>Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day. | Dietary Supplement: Maxicor<br>* Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).<br>* Other names: n-3 PUFA;|
| Placebo Comparator: Placebo<br>Patients will receive placebo (soya oil) | Other: Placebo<br>* Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with decreased liver fat content. | Liver fat content in patients will be measured by magnetic resonance before and after the treatment. The number of patients with decreased liver fat content is expected to be higher in the treated group compare to placebo group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with progression of liver fibrosis. | Liver fibrosis will be measured by ultrasound (ARFI) before and after the treatment. The number of patients with no progression of fibrosis is expected to be higher in the treated group compare to placebo group. | 12 months |