Trials / Completed
CompletedNCT02647294
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- General University Hospital, Prague · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2020-06-01
- Completion
- 2020-06-30
- First posted
- 2016-01-06
- Last updated
- 2023-04-11
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT02647294. Inclusion in this directory is not an endorsement.