Polyunsaturated Fatty Acids in Patients With NAFLD.

General University Hospital, Prague

Status: Completed

Conditions: NAFLD

Treatments: Dietary Supplement: Maxicor; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02647294

15-28745A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with metabolic syndrome and NAFLD

Exclusion criteria

• Age below 18 years
• Gravidity
• Incompliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Polyunsaturated omega-3 fatty acids

Experimental group

Description:

Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.

Treatment:

Dietary Supplement: Maxicor

Placebo

Placebo Comparator group

Description:

Patients will receive placebo (soya oil)

Treatment:

Other: Placebo