NCT02647294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

4.3 years

First QC Date

January 4, 2016

Last Update Submit

April 8, 2023

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of patients with progression of liver fibrosis.

    12 months

Study Arms (2)

Polyunsaturated omega-3 fatty acids

EXPERIMENTAL

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

Dietary Supplement: Maxicor

Placebo

PLACEBO COMPARATOR

Patients will receive placebo (soya oil)

Other: Placebo

Interventions

MaxicorDIETARY_SUPPLEMENT

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

Also known as: n-3 polyunsaturated fatty acids, n-3 PUFA
Polyunsaturated omega-3 fatty acids
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metabolic syndrome and NAFLD

You may not qualify if:

  • Age below 18 years
  • Gravidity
  • Incompliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital

Prague, Prague 2, 128 08, Czechia

Location

Related 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):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.

    PMID: 35147302RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Radan Bruha, MD

    General University Hospital, Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associated professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 30, 2020

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Available upon individual request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Will be available from 6/2023 by the end of 2025.
Access Criteria
Available upon individual request.
More information

Locations

CZ(1)