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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyunsaturated omega-3 fatty acids | Experimental | Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day. |
|
| Placebo | Placebo Comparator | Patients will receive placebo (soya oil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxicor | Dietary Supplement | Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radan Bruha, MD | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | Prague 2 | 128 08 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35147302 | Result | Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11. |
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Available upon individual request.
Will be available from 6/2023 by the end of 2025.
Available upon individual request.
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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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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| Placebo | Other | Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1). |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |