Polyunsaturated Fatty Acids in Patients With NAFLD.

Sponsor

General University Hospital, Prague (Other)

Overall Status

Completed

CT.gov ID

NCT02647294

Collaborator

(none)

Enrollment

Location

Arms

52.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD	Dietary Supplement: Maxicor Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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 polyunsaturated fatty acids n-3 PUFA
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).

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 polyunsaturated fatty acids

n-3 PUFA

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).

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

Age below 18 years
Gravidity
Incompliance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General University Hospital	Prague	Prague 2	Czechia	128 08

Sponsors and Collaborators

General University Hospital, Prague

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radan Bruha, Clinical associated professor, General University Hospital, Prague

ClinicalTrials.gov Identifier:

NCT02647294

Other Study ID Numbers:

15-28745A

First Posted:

Jan 6, 2016

Last Update Posted:

Jul 21, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jul 21, 2020