None listed
Conditions
Brief summary
This study is a multicentre, parallel design, randomised controlled trial, at La Trobe University using cardiology patients from two major Hospitals in Melbourne. The intervention will be 6 months in length with a follow up at 12 months. There will be two groups, the Mediterranean diet intervention arm versus the standard care diet (low fat, National Heart Foundation guidelines) control arm. The aim of this study is to determine whether the Mediterranean diet compared to standard diet intervention can prevent secondary cardiac events and improve cardiometabolic risk factors (lipid profile, inflammatory markers, metabolic parameters, anthropometry, body composition) in a multi-ethnic Australian population.
Interventions
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
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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Exclusion criteria includes participants that: are non-English speaking, have active malignancy, chronic heart failure, chronic inflammatory disease (e.g. Inflammatory bowel disease, Rheumatoid arthritis, renal failure or on dialysis, liver disease), Body mass index (BMI) >40kg/m2, are currently breastfeeding or pregnant, currently participating in an intervention targeting diet or exercise, inability to attend the counselling sessions or examinations, inability to complete the six month dietary intervention due to medical, cultural, social, religious factors or food allergies/intolerances that prevent them from consuming the intervention foods.
Outcome results
None listed