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Polyunsaturated Fatty Acids in Patients With NAFLD.

Primary Purpose

NAFLD

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Maxicor
Placebo
Sponsored by
General University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

  • Age below 18 years
  • Gravidity
  • Incompliance.

Sites / Locations

  • General University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyunsaturated omega-3 fatty acids

Placebo

Arm Description

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

Patients will receive placebo (soya oil)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 4, 2016
Last Updated
April 8, 2023
Sponsor
General University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT02647294
Brief Title
Polyunsaturated Fatty Acids in Patients With NAFLD.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyunsaturated omega-3 fatty acids
Arm Type
Experimental
Arm Description
Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo (soya oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Maxicor
Other Intervention Name(s)
n-3 polyunsaturated fatty acids, n-3 PUFA
Intervention Description
Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).
Primary Outcome Measure Information:
Title
Number of patients with decreased liver fat content.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of patients with progression of liver fibrosis.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with metabolic syndrome and NAFLD Exclusion Criteria: Age below 18 years Gravidity Incompliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radan Bruha, MD
Organizational Affiliation
General University Hospital in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital
City
Prague
State/Province
Prague 2
ZIP/Postal Code
128 08
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://int4.lf1.cuni.cz/en
Citations:
PubMed Identifier
35147302
Citation
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.
Results Reference
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Polyunsaturated Fatty Acids in Patients With NAFLD.

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