Polyunsaturated Fatty Acids in Patients With NAFLD.

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.

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.

Study Overview

• Status: Completed
• Conditions: NAFLD
• Intervention / Treatment: Dietary supplement: Maxicor; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague 2
    • Prague, Prague 2, Czechia, 128 08
      • General University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

• Age below 18 years
• Gravidity
• Incompliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyunsaturated omega-3 fatty acids; Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.	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 Names: n-3 PUFA; n-3 polyunsaturated fatty acids
Placebo Comparator: Placebo; Patients will receive placebo (soya oil)	Other: Placebo; Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General University Hospital, Prague
• Investigators: Principal Investigator: Radan Bruha, MD, General University Hospital in Prague

Publications and helpful links

General Publications

• Yu S, He X, Shi H, Chen Y, Liu Z. Effectiveness of electro-press needle for menopause-associated hot flashes: Protocol of a randomized controlled trial. Medicine (Baltimore). 2022 Feb 11;101(6):e28597. doi: 10.1097/MD.0000000000028597.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 15-28745A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available upon individual request.
• IPD Sharing Time Frame: Will be available from 6/2023 by the end of 2025.
• IPD Sharing Access Criteria: Available upon individual request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR