Clinical Trial Details

Trial ID: L0971
Source ID: NCT00819338
Associated Drug: Efamax
Title: The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease
Acronym: --
Status: Not recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Fatty Liver Disease
Interventions: Dietary Supplement: Efamax
Outcome Measures: Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopySerum liver function tests, lipids, free fatty acids;Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index;Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy;Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin;Primary assessment of the fibrotic and inflammatory status of the liver with serum TGF beta, TNF a, IL-6, IL-8, IL-8, IL-10;Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1;Compliance assessed by serum phospholipid fatty acids
Sponsor/Collaborators: University of Nottingham
Gender: All
Age: 18 Yearsnan
Phases: Phase 2
Enrollment: 58
Study Type: Interventional
Study Designs: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Start Date: 08/01/2009
Completion Date: --
Results First Posted: --
Last Update Posted: 19 February 2015
Locations: United Kingdom
URL: http://clinicaltrials.gov/show/NCT00819338