Polyunsaturated Fatty Acids in Patients With NAFLD.

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Dietary Supplement: Maxicor; Other: Placebo

• Registration Number: NCT02647294
• Lead Sponsor: General University Hospital, Prague

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Study Start: 2016-02
• Primary Completion: 2020-06
• Study Completion: 2020-06-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-08
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with metabolic syndrome and NAFLD

Exclusion Criteria

• Age below 18 years
• Gravidity
• Incompliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyunsaturated omega-3 fatty acids	Maxicor	Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.
Placebo	Placebo	Patients will receive placebo (soya oil)

Primary Outcome Measures

Name	Time	Method
Number of patients with decreased liver fat content.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with progression of liver fibrosis.	12 months	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.

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Prague 2, Czechia