Polyunsaturated Fatty Acids in Patients With NAFLD.

NAFLD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647294
• Other study ID #: 15-28745A
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2023
• Source: General University Hospital, Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

• Age below 18 years

• Gravidity

• Incompliance.

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Maxicor
Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).

Other:
• Placebo
Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague	Prague 2

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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