Abstract

Background and Aims: Dietary risk has a high impact in DALYs in acute ischemic stroke (AIS). Adherence to dietary patterns like the Mediterranean Diet (MeDi) are associated with a decreased risk of stroke mortality/incidence in observational studies and primary prevention trials. Furthermore, lowering Low Density Cholesterol (LDL-C) levels decreases stroke recurrence. Interestingly, Avocado- substituted diets significantly decrease cholesterol levels. Aim: To determine the effect of a MeDi based on Avocados on lipid profile after an AIS. Methods: Methods and patients: Academic, open-label, blinded outcome assessment, controlled clinical trial. Recruitment within a month of AIS if fulfilling eligibility criteria (including consent) and randomly assigned to the diet intervention in a 1:1 ratio. A) Avocado based MeDi with daily intake of 1=2 an avocado B) Low fat-high complex carbohydrate healthy-diet. Study outcomes: Main outcome: Level of plasma LDL-C at 3 months of intervention. Secondary outcomes: Levels of lipid profile, inflammation markers, glycemic control, anthropometric measures, stroke recurrence, cardiovascular events, adverse events, compliance. Sample size estimates: A total sample of 200 patients was estimated to provide 80% power and 5% level of significance (10% loss and 5% cross- over) to detect a 4.6 ml/dL difference of in LDL-C. The study has ethics committee approval. Results: The trial is progressing as planned. From August 2018 to February 2019, 25 patients have been recruited and 15 have completed 3-month follow-up. Conclusion: We hypothesize that an Avocado based MeDi will signifi- cantly reduce levels of LDL-cholesterol at 3 months in patients who have suffered an AIS compared to the control diet. Trial registration number: ADDSPISE Clinical Trials.gov Identifier NCT03524742.