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. 2019 Mar 13;2019(3):CD009825. doi: 10.1002/14651858.CD009825.pub3

Davis 2017.

Methods RCT of parallel‐group design
Participants 166 Australian men and women recruited from Adelaide aged greater than 64 years and free of any cardiovascular, liver, kidney, respiratory or gastrointestinal disease, cognitive impairment, type 1 or 2 diabetes, malignancy in the past 6 months, major recent head trauma or a significant psychiatric disorder
Participants with blood pressure above 160/100 mmHg were excluded
Mean age 71 years; 44% men
Interventions The intervention diet was based on a traditional Mediterranean diet, with small adaptations to the Australian food supply. The diet comprised extra‐virgin olive oil, vegetables, fruit, nuts, whole grains, legumes and fish as core foods. It was moderate in red wine and dairy foods and contained small amounts of red meat. Participants attended the clinic biweekly to meet with a dietitian to ensure high adherence to the dietary protocol. Resources were provided that included a recipe book, guidelines for eating out, serving sizes and the recommended number of servings, and participants also received foods (olive oil, nuts, legumes, tuna and Greek yogurt) to increase the likelihood of adherence. The following recommendations were given: abundant use of extra‐virgin olive oil (≥ 1 tbsp/day), 5 to 6 servings of vegetables/day, ≥ 2 servings of fresh fruit/day, 4 to 6 servings of whole grain cereals/day, 4 to 6 servings of nuts/week, 3 servings legumes/week, 3 servings of fish (1 oily)/week, less than 1 serving of red meat/week, limit consumption of discretionary foods to ≤ 3 times/week.
The control group were told to consume a regular diet without change (seasonal variation permitted) and received a voucher to buy regularly consumed foods from supermarkets
Both groups were required to maintain their physical activities and medication and dietary supplement use throughout the intervention
6 months intervention and follow‐up
Outcomes Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Notes The MedDiet for cardiovascular and cognitive health in the elderly (MedLey) study: primary outcome was cognitive function, CVD risk factors were secondary outcomes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Volunteers were randomly allocated to either the control group or the intervention group stratified by gender, BMI and age by the process of minimisation
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk The researcher who administered the cognitive test battery and assessed and scored cognitive outcomes was blind to group assignment and will remain blind until after data analysis to reduce bias. No information regarding CVD risk factors.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The researcher who administered the cognitive test battery and assessed and scored cognitive outcomes was blind to group assignment and will remain blind until after data analysis to reduce bias. No information regarding CVD risk factors.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Reasons for withdrawal or missing data were associated with the assigned treatment in 2 participants only. Therefore, missing data for participants who were not included in the final analysis were assumed to be missing at random. Overall attrition over 6 months was 17%.
Selective reporting (reporting bias) Low risk Report includes all specified outcomes
Other bias Unclear risk Insufficient information to judge