Effect of a Mediterranean diet with fresh lean Australian pork on blood pressure, cardiovascular risk factors and cognition, mood and wellbeing in high risk individuals.

INTERVENTION: This is a randomised cross‐over dietary intervention trial with two 8‐week dietary phases (Mediterranean diet and low fat diet) separated by an 8 week washout period. Total duration of the trial is 24 weeks. Outcome measures will be recorded at the start and end of each 8 week phase (ie baseline, week8, week 16, week 24). At baseline volunteers will meet with the dietitian, for approximately 30mintues, and received instructions regarding their dietary prescription for the next 8 weeks. Volunteers will be prescribed their allocated diet, receive recipes and their sample menu (during Mediterranean diet) to help guide food choices. Volunteers will be given advice on eating out strategies to assist with compliance to their allocated diet.They will be issued a diet checklist to ensure they are complying with the diet. During the MedDiet phase, volunteers will receive lean fresh Australian pork plus foods characteristic of the MedDiet (olive oil, canned fish, nuts etc) to assist with compliance. All volunteers will be asked to maintain their usual exercise pattern. Volunteers will be asked to return fortnightly to see the dietitian (for 15‐30 minutes), have their weight measured, return checklists, collect study foods and discuss any problems that may have arisen during the intervention. During the washout periods between diet phases, volunteers will be asked to return to following their habitual diet. Mediterranean Diet (MedDiet) with pork. The MedDiet is characterised by a variety of foods including wholegrain cereals, nuts, legumes, extra virgin olive oil, red wine, small amounts of red meat, low intakes of dairy (mainly yoghurt and cheese), fish, fruits and vegetables. The MedDiet will be based on the PREDIMED‐EVOO diet as described by Estruch R et al (NEJM 2013) and fresh lean pork will be included as an alternative option for protein food. Guidelines for following the MedDiet are adapted from Estruch R et al 2013 NEJM, include: Abundant use of extra virgin olive oil for cooking and dressing vegetables and salads 2‐3 or more daily servings of fresh fruits including 100% natural juices 3 or more weekly servings of legumes (75g per serve) 3 or more weekly servings of fish and seafood (at least one serving of oily fish) (100g per serve) 3 or more weekly serving of nuts (7.5g hazelnuts, 15g walnuts, 7.5g almonds) or seeds (30g per serve) Ad‐libitum consumption of wholegrain cereal products (bread, pasta, rice, cereal), nuts, fish, eggs, cheese and raw and cooked vegetables. Select white meats (poultry without skin) instead of red meats or processed meats (burgers, sausages, deli meats) Limit consumption of cured ham, red meat (remove all visible fat) to 1 or less serve/week Remove chicken skin Cook regularly (at least twice a week) with tomato, garlic and onion Dress vegetables, pasta, rice and other dishes with tomato, garlic and onion Eliminate or limit the consumption of cream, butter, margarine and discretionary foods Adherence to the MedDiet will be assessed using a 14‐point adherence score assessed fortnightly. Compliance to the MedDiet will be assessed from weighed food records conducted at the beginning and end of each dietary phase and through daily checklists. All volunteers will see the dietitian fortnightly who will discuss strategies to maintain compliance to the MedDiet. CONDITION: Cardiometabolic Health Cardiovascular Health Wellbeing and cognitive performance ; ; The CAIDE will be assessed in volunteers aged between 45‐65 years (validated in this age range) INCLUSION CRITERIA: Free‐living non‐smoking men and women, aged between 45‐75 years with elevated SBP equal to or above 120mmHg (high‐normal range) and not on antihypertensive medication, PRIMARY OUTCOME: Blood pressure will be determined by automatic oscillatory using a Digital Blood Pressure Monitor. Volunteers will monitor blood pressure three times a day, at home, for 6 days generating 54 data points of blood pressure readings where the average will be taken. ; Plasma C‐reactive protein (inflammatory marker) Plasma high density lipoprotein (HDL) cholesterol levels Plasma levels of glucose will be assessed using standard methods via venepuncture. Finger prick glucose will be taken using a lancet and measured using a glucometer at screening. Plasma low denstiy lipoprotein (LDL) cholesterol levels Plasma total Cholesterol levels Plasma triglyceride levels Serum levels of insulin Social health‐related quality of life will be assessed using the Short Form Health Survey (SF36V2) The CAIDE Dementia Risk score was developed to identify individuals at increased risk for developing dementia (20 years later) based on midlife presence of metabolic and vascular risk factors that would potentially benefit from preventative interventions to reduce their risk (Sindi 2015). ; Waist and hip circumference (in centimeters) will be measured according to the ISAK International Standards for Anthropometric Assessment. Waist/Hip ratio will be calculated by dividing waits/hip circumference. who habitually consume 1 or less serves of fresh pork per week WITH at least 2 risk factors for CVD: 1. overweight/obese with BMI equal to or above 25kg/m2 2. waist circumference men greater than94cm, women greater than 80cm 3. dyslipidemia one of the following: total cholesterol equal to or greater than 5.5mM, triglycerides equal to or greater than 2.0mM, LDL equal to or greater than 3.5, HDL men equal to or less than 0.9 women less than 1.0, 4. impaired glucose tolerance (fasted glucose between 6.1‐7.8mmol/L) 5. Family history of CVD (MI or sudden death before 55yrs for men or 65yrs for female 1st degree relatives) 6. Family history of type 2 diabetes mellitus (T2DM) SECONDARY OUTCOME: % body fat, assessed by dual X‐ray absorptiometry (DEXA) Abdominal Body fat (DEXA) Addenbrooke's Cognitive Examination Revised (ACE‐R) is a brief cognitive test battery that has been validated for use to detect early cognitive dysfunction through scoring five different cognitive domains (memory, attention/orientation, fluency, language and visouspatial). (Mioshi et al 2006) This will be used at screening to rule out dementia and Alzhemier's disease and as an outcome measure as it is sensitive in detecting very mild‐cognitive impairment. Apolipoprotein E‐4 allele (APOE4, indicator of increased risk for Alzheimer's Disease) as assessed from blood sample using the TaqMan 'registered trademark' SNP Genotyping Assay Kit (Applied Biosystems, Warrington, UK) (Koch et al 2002) Body Mass Index, calculated as weight divided by height in meters squared. Weight will be measured using digital scales while volunteers are wearing minimal clothing and no shoes. Height will be measured at baseline using a wall‐mounted stadiometer. Cognitive performance will be assessed using the CANTAB 'registered trademark' computerised test battery: decision making Cognitive performance will be assessed using the CANTAB 'registered trademark' computerised test battery: executive function Cognitive performance will be assessed using the CANTAB 'registered trademark' computerised test battery: social cognition Cognitive performance will be assessed using the CANTAB 'registered trademark' computerised test battery: speed of processing (reaction and attention) Cognitive performance will be assessed using the CANTAB 'registered trademark' computerised test battery: visual and verbal memory. Energy and macro and micronutrient intakes will be calculated from 6 day weighed food records entered into Foodworks Professional Software program. Faecal Microbiome profile. The omnigene GUT collection system will provide an easy non‐invasive stool collection kit for volunteers to use at home. Fat Mass (DEXA) Framingham Risk Score is a gender specific calculator used to estimate an individual's 10 year risk of developing cardiovasular disease. Heart Rate, measured by automatic oscillometry. In‐clinic assessed blood pressure will be determined by automatic oscillatory using a Digital Blood Pressure Monitor. On each occasion 3 readings will be taken spaced at least 1 minute apart, and the average of the readings will be used. Insulin Resistance calculated from serum insulin and glucose. Insulin resistance will be calculated using the Homeostasis Model Assessment (HOMA2) Calculator. Lean Mass (DEXA) Low Fat Dietary Adherence using the 9‐point low fat diet adherence tool (Estruch et al 2013). Mediterranean Dietary Adherence using the 14‐point MedDiet adherence tool and weighed food records. Mental health‐related quality of life; will be assessed using the Short Form Health Survey (SF36V2) Mood will be assessed using the Profile of Mood State (POMS) questionnaire (McNair 1971). Physical health‐related quality of life will be assessed using the Short Form Health Survey (SF36V2)