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

Abstract

BackgroundNon-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.MethodsNinety 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.DiscussionThis 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.Trial registrationAustralia and New Zealand Clinical Trials Register ACTRN: ACTRN12615001010583.

Non‐alcoholic fatty liver disease patients attending two metropolitan hospitals in Melbourne, Australia: high risk status and low prevalence

“…23 Data were collected for 10 consecutive months at each respective site between October 2014 and June 2016. 23 Data were collected for 10 consecutive months at each respective site between October 2014 and June 2016.…”

Nutritional approaches for managing obesity-associated metabolic diseases

“…Given the beneficial effects of dietary approaches for reducing body weight and adiposity, it is interesting to also examine whether the same approaches result in beneficial effects on hepatic steatosis. Indeed, there is an ongoing randomized controlled trail to examine whether consumption of a Mediterranean diet reduce liver fats (Papamiltiadous, et al 2016). There is a hope that more this type of trials will be performed in near future.…”

Nutritional Approaches to Achieve Weight Loss in Nonalcoholic Fatty Liver Disease

“…A significant relative reduction in hepatic steatosis and improvement in insulin sensitivity was observed in the patients who followed the Mediterranean diet compared with those on a low-fat, high-carbohydrate diet (39% 6 4% compared with 7% 6 3%, respectively, P = 0.012) (80). Based on this pilot study, a larger randomized controlled trial called the Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease is now underway and currently enrolling patients until 2017 (81). This was further corroborated by another study in which NASH patients were noted to have lower adherence to the Mediterranean diet than were NAFLD patients (82).…”