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A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA): study protocol

Overview of attention for article published in BMC Gastroenterology, February 2016
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Title
A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA): study protocol
Published in
BMC Gastroenterology, February 2016
DOI 10.1186/s12876-016-0426-3
Pubmed ID
Authors

Elena S. Papamiltiadous, Stuart K. Roberts, Amanda J. Nicoll, Marno C. Ryan, Catherine Itsiopoulos, Agus Salim, Audrey C. Tierney

Abstract

Non-alcoholic fatty liver disease, the most prevalent liver disease in developed countries, remains difficult to manage with no proven safe and effective pharmacotherapy available. While weight reduction is the most commonly practiced treatment strategy, this is difficult to both achieve and/or maintain in the majority. Furthermore evidence-based dietary recommendations to guide the nutritional management of these patients are lacking. Using a randomised controlled trial design, this study compares the effectiveness of the Mediterranean diet to a standard low fat diet in terms of differences in insulin sensitivity, hepatic steatosis and metabolic outcomes in participants with non-alcoholic fatty liver disease. Ninety four eligible patients who have non-alcoholic fatty liver disease and who are insulin resistant, will be randomised into either a Mediterranean or low fat diet group for a 3 month intervention period. Insulin sensitivity will be measured on peripheral blood using Homeostatic Model Assessment and liver fat content quantified using Magnetic Resonance Spectroscopy. Both arms will consist of three face to face and three telephone call follow up consultations delivered by an Accredited Practicing Dietitian. The intervention arm focuses on recommendations from the traditional Mediterranean diet which have been tailored for use in the Australian population The standard arm uses the Australian Guide to Healthy Eating and the Australian National Heart Foundation dietary guidelines. Study recruitment will take place at four major metropolitan hospitals in Melbourne, Australia. Data collection will occur at all face to face reviews including baseline, 6, and 12 weeks. A follow up assessment to measure sustainability will take place at 6 and 12 months. The primary end point is improved insulin sensitivity scores at the 12 week time point. This trial aims to demonstrate in a large cohort of participants with NALFD that a Mediterranean diet independent of weight loss can result in significant benefits in liver fat and insulin sensitivity and that these changes are sustained at 12 months. These metabolic changes would potentially lead to reductions in the risk of chronic liver disease, heart disease, type 2 diabetes and liver cancer. Australia and New Zealand Clinical Trials Register ACTRN: ACTRN12615001010583 .

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Mendeley readers

The data shown below were compiled from readership statistics for 248 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 248 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 46 19%
Student > Master 36 15%
Student > Ph. D. Student 22 9%
Researcher 20 8%
Student > Postgraduate 16 6%
Other 37 15%
Unknown 71 29%
Readers by discipline Count As %
Medicine and Dentistry 59 24%
Nursing and Health Professions 40 16%
Biochemistry, Genetics and Molecular Biology 18 7%
Agricultural and Biological Sciences 18 7%
Psychology 10 4%
Other 25 10%
Unknown 78 31%