title: Omega-3 polyunsaturated fatty acids in treating non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled trial.
abstract: & aims: Few clinical trials have addressed the potential benefits of omega-3 polyunsaturated fatty acids (PUFAs) on non-alcoholic steatohepatitis (NASH). We evaluated the effects of supplementation with omega-3 PUFAs from flaxseed and fish oils in patients with biopsy-proven NASH.
  
  
  
  Patients received three capsules daily, each containing 0.315 g of omega-3 PUFAs (64% alpha-linolenic [ALA], 16% eicosapentaenoic [EPA], and 21% docosahexaenoic [DHA] acids; n-3 group, n = 27) or mineral oil (placebo group, n = 23). Liver biopsies were evaluated histopathologically by the NASH activity score (NAS). Plasma levels of omega-3 PUFAs were assessed as a marker of intake at baseline and after 6 months of treatment. Secondary endpoints included changes in plasma biochemical markers of lipid metabolism, inflammation, and liver function at baseline and after 3 and 6 months of treatment.
  
  
  
  At baseline, NAS was comparable between the groups (p = 0.98). After intervention with omega-3 PUFAs, plasma ALA and EPA levels increased (p ≤ 0.05). However in the placebo group, we also observed increased EPA and DHA (p ≤ 0.05), suggesting an off-protocol intake of PUFAs. NAS improvement/stabilization was correlated with increased ALA in the n-3 group (p = 0.02) and with increased EPA (p = 0.04) and DHA (p = 0.05) in the placebo group. Triglycerides were reduced after 3 months in the n-3 group compared to baseline (p = 0.01).
  
  
  
  In NASH patients, the supplementation of omega-3 PUFA from flaxseed and fish oils significantly impacts on plasma lipid profile of patients with NASH. Plasma increase of these PUFAs was associated with better liver histology. (ID 01992809).
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Clinical Division of Clinical Gastroenterology and Hepatology (LIM-07), São Paulo, Brazil.
authors.forename: Monize Aydar
authors.initials: MA
authors.lastname: Nogueira
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Clinical Division of Clinical Gastroenterology and Hepatology (LIM-07), São Paulo, Brazil.
authors.forename: Claudia Pinto
authors.initials: CP
authors.lastname: Oliveira
authors.affiliation: University of São Paulo School of Medicine, Department of Pathology (LIM-14), São Paulo, Brazil.
authors.forename: Venâncio Avancini
authors.initials: VA
authors.lastname: Ferreira Alves
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Clinical Division of Clinical Gastroenterology and Hepatology (LIM-07), São Paulo, Brazil.
authors.forename: José Tadeu
authors.initials: JT
authors.lastname: Stefano
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Surgery Division (LIM-35), São Paulo, Brazil.
authors.forename: Lívia Samara Dos Reis
authors.initials: LS
authors.lastname: Rodrigues
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Surgery Division (LIM-35), São Paulo, Brazil.
authors.forename: Raquel Susana
authors.initials: RS
authors.lastname: Torrinhas
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Clinical Division of Clinical Gastroenterology and Hepatology (LIM-07), São Paulo, Brazil.
authors.forename: Bruno
authors.initials: B
authors.lastname: Cogliati
authors.affiliation: University of São Paulo School of Medicine, Department of Emergency (LIM-51), Sao Paulo, Brazil.
authors.forename: Hermes
authors.initials: H
authors.lastname: Barbeiro
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Clinical Division of Clinical Gastroenterology and Hepatology (LIM-07), São Paulo, Brazil.
authors.forename: Flair José
authors.initials: FJ
authors.lastname: Carrilho
authors.affiliation: University of São Paulo School of Medicine, Department of Gastroenterology, Surgery Division (LIM-35), São Paulo, Brazil. Electronic address: dan@ganep.com.br.
authors.forename: Dan Linetzky
authors.initials: DL
authors.lastname: Waitzberg
mesh_terms: D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D001938:Brazil; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D005395:Fish Oils / Q000009:adverse effects / Q000627:therapeutic use*; D006784:Hospitals, Teaching; D006801:Humans; D015228:Hypertriglyceridemia / Q000209:etiology / Q000517:prevention & control; D008043:Linseed Oil / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000276:immunology / Q000378:metabolism / Q000473:pathology* / Q000503:physiopathology; D059012:Lost to Follow-Up; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000178:diet therapy* / Q000276:immunology / Q000378:metabolism / Q000473:pathology; D010349:Patient Compliance; D010352:Patient Dropouts; D015203:Reproducibility of Results; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers; D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D008043:Linseed Oil
keywords: Alpha-linolenic acid; Docosahexaenoic acid; Eicosapentaenoic acid; Fish oil; Flaxseed oil; Nonalcoholic steatohepatitis