E Scorletti1, L Bhatia2, K G McCormick3, G F Clough3, K Nash4, P C Calder2, C D Byrne2. 1. Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address: e.scorletti@soton.ac.uk. 2. Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK. 3. Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK. 4. Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Abstract
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) represents a range of liver conditions from simple fatty liver to progressive end stage liver disease requiring liver transplantation. NAFLD is common in the population and in certain sub groups (e.g. type 2 diabetes) up to 70% of patients may be affected. NAFLD is not only a cause of end stage liver disease and hepatocellular carcinoma, but is also an independent risk factor for type 2 diabetes and cardiovascular disease. Consequently, effective treatments for NAFLD are urgently needed. OBJECTIVES: The WELCOME study is testing the hypothesis that treatment with high dose purified long chain omega-3 fatty acids will have a beneficial effect on a) liver fat percentage and b) two histologically validated algorithmically-derived biomarker scores for liver fibrosis. DESIGN: In a randomised double blind placebo controlled trial, 103 participants with NAFLD were randomised to 15-18months treatment with either 4g/day purified long chain omega-3 fatty acids (Omacor) or 4g/day olive oil as placebo. Erythrocyte percentage DHA and EPA enrichment (a validated proxy for hepatic enrichment) was determined by gas chromatography. Liver fat percentage was measured in three discrete liver zones by magnetic resonance spectroscopy (MRS). We also measured body fat distribution, physical activity and a range of cardiometabolic risk factors. METHODS: Recruitment started in January 2010 and ended in June 2011. We identified 178 potential participants, and randomised 103 participants who met the inclusion criteria. The WELCOME study was approved by the local ethics committee (REC: 08/H0502/165; www.clinicalTrials.gov registration number NCT00760513).
RCT Entities:
BACKGROUND:Non-alcoholic fatty liver disease (NAFLD) represents a range of liver conditions from simple fatty liver to progressive end stage liver disease requiring liver transplantation. NAFLD is common in the population and in certain sub groups (e.g. type 2 diabetes) up to 70% of patients may be affected. NAFLD is not only a cause of end stage liver disease and hepatocellular carcinoma, but is also an independent risk factor for type 2 diabetes and cardiovascular disease. Consequently, effective treatments for NAFLD are urgently needed. OBJECTIVES: The WELCOME study is testing the hypothesis that treatment with high dose purified long chain omega-3 fatty acids will have a beneficial effect on a) liver fat percentage and b) two histologically validated algorithmically-derived biomarker scores for liver fibrosis. DESIGN: In a randomised double blind placebo controlled trial, 103 participants with NAFLD were randomised to 15-18months treatment with either 4g/day purified long chain omega-3 fatty acids (Omacor) or 4g/day olive oil as placebo. Erythrocyte percentage DHA and EPA enrichment (a validated proxy for hepatic enrichment) was determined by gas chromatography. Liver fat percentage was measured in three discrete liver zones by magnetic resonance spectroscopy (MRS). We also measured body fat distribution, physical activity and a range of cardiometabolic risk factors. METHODS: Recruitment started in January 2010 and ended in June 2011. We identified 178 potential participants, and randomised 103 participants who met the inclusion criteria. The WELCOME study was approved by the local ethics committee (REC: 08/H0502/165; www.clinicalTrials.gov registration number NCT00760513).
Authors: Geraldine F Clough; Keith G McCormick; Eleonora Scorletti; Lokpal Bhatia; Philip C Calder; Michael J Griffin; Christopher D Byrne Journal: Diabetologia Date: 2016-04-22 Impact factor: 10.122
Authors: Keith G McCormick; Eleonora Scorletti; Lokpal Bhatia; Philip C Calder; Michael J Griffin; Geraldine F Clough; Christopher D Byrne Journal: Diabetologia Date: 2015-05-29 Impact factor: 10.122
Authors: Asmaa S Abdelhamid; Tracey J Brown; Julii S Brainard; Priti Biswas; Gabrielle C Thorpe; Helen J Moore; Katherine Ho Deane; Fai K AlAbdulghafoor; Carolyn D Summerbell; Helen V Worthington; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-11-30
Authors: Asmaa S Abdelhamid; Nicole Martin; Charlene Bridges; Julii S Brainard; Xia Wang; Tracey J Brown; Sarah Hanson; Oluseyi F Jimoh; Sarah M Ajabnoor; Katherine Ho Deane; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-11-27
Authors: Asmaa S Abdelhamid; Tracey J Brown; Julii S Brainard; Priti Biswas; Gabrielle C Thorpe; Helen J Moore; Katherine Ho Deane; Fai K AlAbdulghafoor; Carolyn D Summerbell; Helen V Worthington; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-07-18
Authors: Asmaa S Abdelhamid; Nicole Martin; Charlene Bridges; Julii S Brainard; Xia Wang; Tracey J Brown; Sarah Hanson; Oluseyi F Jimoh; Sarah M Ajabnoor; Katherine Ho Deane; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-07-18
Authors: Asmaa S Abdelhamid; Tracey J Brown; Julii S Brainard; Priti Biswas; Gabrielle C Thorpe; Helen J Moore; Katherine Ho Deane; Carolyn D Summerbell; Helen V Worthington; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2020-02-29