The AUSMED Heart Trial: The Australian Mediterranean diet trial for secondary prevention of heart disease

INTERVENTION: Mediterranean diet versus standard diet. Patients are randomised to either the Mediterranean diet intervention arm or the standard diet (low fat, National Heart Foundation guidelines, Australian Guide to Healthy Eating) control arm. Participants of both study arms will receive individualised counselling from an Accredited Practicing Dietitian (APD) across a 6 month period and then a phone call follow up at 12 months. The consults with an APD will be face‐to‐face at baseline, mid‐intervention (3 months) and end of intervention (6 months). For these appointments diet adherence will be assessed through food diaries and food frequency questionnaire, blood/urine samples taken, activity levels monitored via accelerometer and anthropometric measures and DEXA scans performed. Each face‐to‐face appoint will take approximately 1.5 to 2 hours. Review phone calls (approximately 15 minutes each) will also be conducted every 3 weeks up until the 3 month review appointment and on a monthly basis up until counselling cessation at 6 months. A final follow up phone call of approximately 20 minutes duration will be conducted at 12 months to assess feasibility of sustaining the diet. Meal plans and recipes relevant to the diet group are provided at baseline. The Mediterranean diet intervention is prescribed ad libitum and composed of a high fat (approximately 40% of total energy intake), moderate carbohydrate and moderate protein intake. Key foods promoted are extra virgin olive oil, nuts, legumes, wholegrains, fruits, vegetables, seafood, fermented dairy products, herbs and spices, with limited intake of red meat. To achieve dietary goals, the intervention group are provided with a food hamper representing typical Mediterranean diet foods (olive oil, nuts, natural Greek yoghurt, tinned fish and legumes) and the control standard diet group are provided a supermarket voucher to purchase low fat/recommended healthy food products. These will be provided at baseline and 3 month appointments. CONDITION: Cardiovascular Disease Coronary Heart Disease Type 2 Diabetes PRIMARY OUTCOME: Cardiac endpoints (Acute Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty, cardiovascular mortality, all‐cause mortality) measured via self‐report, hospital medical records and death registry. INCLUSION CRITERIA: Eligible participants will be high risk cardiology patients who have experienced a cardiac event with acute presentation to The Northern Hospital or St Vincent's Hospital. Cardiac event includes participants who have suffered an acute myocardial infarction (AMI) (stemi or non‐stemi infarct), angina pectoris or have had coronary artery bypass surgery (CABG), balloon angioplasty (with or without stent). Participants will also be included if they have type 2 diabetes or metabolic syndrome. SECONDARY OUTCOME: Activity levels measured via triaxial Actigraph accelerometers, worn across a 7‐day continuous period. Adhesion molecule markers of endothelial function, including soluble intracellular adhesion molecule‐1and Vascular cell adhesion molecule‐1, using serum blood analysis. Adipokine markers, including a composite of Adiponectin (anti‐inflammatory) and Resitin (inflammatory), using serum blood analysis. Anthropometric measures as a composite of body mass index, incorporating weight (calibrated stand‐on scales) and height, and waist, hip, neck circumferences. Blood lipid/metabolic profile ‐ assessing fasting total cholesterol, LDL, HDL, Triglycerides and glucose from serum levels in blood. Blood pressure will be measured using sphygmomanometer. Body composition ass measured by DEXA scan to assess changes in fat and lean muscle mass. Coagulation factors (Fibrinogen, Antithrombin III, factor VII, factor VIII, Plasminogen activator inhibitor‐1) using plasma blood analysis Dietary adherence to Mediterranean diet versus low fat/moderate carbohydrate interventions will be measured via self‐reported 7‐day food diaries, tailored cardiology food frequency questionnaire and validated 14‐item Mediterranean diet adherence score (PREDIMED study) as well as objective measures of compliance including plasma carotenoids, plasma fatty acids and urinary hydroxytyrosol.. Inflammatory cytokine markers, including a composite of high sensitivity C‐Reactive Protein and Interleukin‐6, using serum blood analysis. Quality of Life measure via SF 36 Questionnaire.