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The effect of a Mediterranean diet with adequate dairy foods on cardio-metabolic and cognitive health outcomes

The effect of a Mediterranean Diet, with adequate dairy foods, to meet Australian recommendations, on cardiometabolic and cognitive health outcomes in men and women at high risk of cardiovascular disease.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000309482
Acronym
MedDairy
Enrollment
43
Registered
2016-03-09
Start date
2016-04-08
Completion date
2016-06-09
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In a crossover study, we aim to determine whether a Mediterranean diet with adequate dairy foods, consumed over 8 weeks, will improve measures of blood pressure, cardiometablic health, wellbeing and cognitive performance, more than a low fat diet in an high risk population of men and women with for cardiovascular disease (CVD). We believe that volunteers consuming a Mediterranean diet enriched with dairy foods (MedDairy diet), to meet the nutrient reference values for calcium in Australia, will have greater improvements in blood pressure than a low fat diet, based on Heart Foundation recommendations. Low fat diets are recommended for treatment of many chronic diseases such as type 2 diabetes mellitus, heart health and secondary prevention of stroke etc. together with regular physical activity. We know that the MedDiet, rich in bioactive foods and nutrients, has significant effects on longevity as well as reduced total death and death from CVD. Furthermore, given the independent reported health benefits of dairy foods on CVD risk factors including blood pressure, blood lipids etc. a diet combing both a Mediterranean diet and dairy foods (MedDairy diet) may in fact improve indices of cardiovascular health more than a low fat diet.

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 weeks. At baseline, volunteers will meet with the dietitian, for approximately 30 minutes, and receive instructions regarding their dietary prescription for the next 8 weeks. Volunteers will be prescribed their allocated diet, receive a recipe book (The Mediterranean Diet, Catherine Itsiopoulos,

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. At baseline, volunteers will meet with the dietitian, for approximately 30 minutes, and receive instructions regarding their dietary prescription for the next 8 weeks. Volunteers will be prescribed their allocated diet, receive a recipe book (The Mediterranean Diet, Catherine Itsiopoulos, Pan Macmillan Australia Pty Ltd) and a sample menu (if MedDairy group) 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 MedDairy phase, volunteers will receive 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 DAIRY diet (MedDairy) The MedDiet is characterised by a variety of foods including wholegrain cereals, nuts, legumes, olive oil, red wine, small amounts of red meat, low intakes of dairy (mainly yoghurt and cheese), fish, red wine, fruits and vegetables. For this study the MedDairy diet will be based on the PREDIMED-EVOO diet however volunteers will consume 3-4 serves of low-fat and regular dairy products including cheese, milk and yoghurt. To ensure we meet the Australian recommendations for dairy foods, we are recommending 3-4 serves of dairy foods per day. Guidelines for following the MedDairy diet are adapted from Estruch R et al 2013 NEJM, include: Abundant use of extra virgin olive oil for cooking and dressing vegetables and salad 3-4 daily servings of reduced fat milk (1 cup), yoghurt (200g) and tzatziki dip (200g), regular fat cheese (40g hard/semi-soft cheese, 120 g soft cheese) 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 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 Low-fat diet (LFD) The LFD will be based on the PREDIMED control diet (Estruch R et al 2013 NEJM) following American Heart Association in combination with local recommendations for the Heart Foundation of Australia. Volunteers will maintain the basis of their habitual diet however will be asked to modify their intake to choose low fat foods. Specifically : cook with little fat, remove / skim fats from foods, choose and purchase low fat foods

Sponsors

Dr Karen Murphy
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Free-living non-smoking men and women aged between 45 to 75 years with elevated systolic BP between 120mmHg and 140mmHg (high-normal range) and not on antihypertensive medication with at least 2 risk factors for cardiovascular disease (CVD): overweight/obese with body mass index 25kg/m2 or above waist circumference men >94cm, women >80cm dyslipidemia one of the following (fasted) : total cholesterol 5.5mM or above, triglycerides 2.0mM or above, low density lipoprotein cholesterol (LDL) 3.5 or above, high density lipoprotein cholesterol (HDL) men 0.9 and women 1.0 or below, impaired glucose tolerance (fasting glucose <7.0mmol/L) family history of CVD (myocardial infarction or sudden death before 55yrs for men or 65yrs for female 1st degree relatives) Family history of type 2 diabetes mellitus (T2DM)

Exclusion criteria

Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol Previous/current traumatic head/brain injury, neurological or psychiatric conditions Previous stroke Use of anti-depressant, anxiety or neurological or psychiatric medication Current or recent (in the last 6 months) malignancy Major liver, kidney, respiratory, gastrointestinal disease Current CVD or angina Actively trying to lose weight Pregnancy/lactating Smoker Diagnosed T2DM Allergy/sensitivity to nuts, seafood, dairy foods etc. Illegal drug use or alcoholism Weight >135kg (DEXA limitations) Diagnosis of Alzheimer’s disease or dementia

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026