RecruitingACTRN12616001046493

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.


Sponsor

University of South Australia

Enrollment

39 participants

Start Date

Jan 25, 2017

Study Type

Interventional

Conditions

Summary

The aim of this project is to determine the effect of a Mediterranean diet with lean fresh pork in comparison with a low fat diet on risk factors for CVD and cognitive function, mood and wellbeing in a randomised crossover dietary intervention trial in a population of men and women at risk of CVD. The primary outcome is home measured blood pressure (BP). Secondary outcomes include the Framingham heart risk score, dementia risk score, mood, wellbeing, cognitive performance (memory, executive function, speed of processing visual spatial and attention), blood lipids, insulin, glucose, insulin resistance, C Reactive Protein, erythrocyte fatty acids, apolipoprotein E4, body mass index, abdominal adiposity and body composition, weight, waist:hip ratio, gut microbiome profile, clinic blood pressure, dietary intake data and Mediterranean dietary adherence and low fat dietary adherence. This is a randomised crossover dietary intervention trial with 39 men and women aged 45-75 years at high risk of CVD. They will be included if they have systolic blood pressure greater than 120mmHg PLUS at least two risk factors for CVD including : BMI >25kg/m2 (overweight), abdominal adiposity, impaired glucose tolerance, dyslipidemia, family history of CVD or type 2 diabetes. Half the group will be randomly allocated to commence with either a Mediterranean diet with pork (MedDiet) or a lowfat diet (control current best practice) for 8weeks, then move to a washout diet for 8 weeks (habitual diet) then move to the other diet for the remaining 8weeks. At the start and end of each 8 week dietary phase volunteers will have all outcomes measured. Following an overnight fast, volunteers will attend their clinic visit and will have the following outcomes measured prior to breakfast: Height, weight Waist/hip circumference Blood pressure 40mL blood sample DEXA scan to assess body composition Following a light standard continental breakfast; Cognitive performance will be measured. Volunteers will meet with the dietitian and receive instructions regarding their dietary prescription for the next 8 weeks. They will be issued a diet checklist to ensure they are complying with the diet and receive some food staples. During this appointment volunteers will return items that were issued to them 1 week prior; their blood pressure monitors and 6day readings, together with their 3day weighed food record, faecal specimen and questionnaires. All volunteers will be asked to maintain their usual exercise pattern throughout the study.. Volunteers will be asked to return fortnightly during each diet phase to see the dietitian.


Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for men and women aged 45–75 who are at risk of heart disease. It tests whether a Mediterranean-style diet that includes lean fresh pork lowers blood pressure and improves heart health, thinking ability, and mood more than a standard low-fat diet. Each participant tries both diets over different periods and results are compared. You may be eligible if: - You are between 45 and 75 years old - You are a non-smoker - Your systolic blood pressure is at or above 120 mmHg and you are not on blood pressure medicine - You eat one serve or less of fresh pork per week - You have at least 2 of these risk factors: overweight (BMI over 25), large waist, high cholesterol, borderline high blood sugar, family history of heart disease or diabetes You may NOT be eligible if: - You have diagnosed heart disease, angina, or have had a stroke - You have Type 2 diabetes - You are actively trying to lose weight - You are pregnant or breastfeeding - You smoke - You have a neurological or psychiatric condition - You have a food allergy relevant to the diet (e.g., nuts, seafood) - You have Alzheimer's disease or dementia Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

SA, Australia

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ACTRN12616001046493


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