Effects of an Avocado Based meDiterranean Diet on Serum Lipids for Secondary Prevention After Ischemic StrokE Trial. Study Protocol.

Summary

Recent global burden of disease analysis of DALYs, showed that dietary risk have the highest DALYs in ischemic stroke among behavioral risk factors. The MediDiet is associated with a decreased risk of total mortality as well as stroke incidence and mortality. Although not part of the classical Mediterranean diet they are another nutrient-dense source of MUFA, rich in vitamins, minerals, fiber, phytosterols and polyphenols extensively consumed in the Americas. Avocado-substituted diets significantly decrease cholesterol levels in diabetic and obese patients. Secondary stroke prevention studies with diet as an intervention are lacking and there is little information of what patients eat before or after an ischemic stroke. Lowering Low Density Cholesterol (LDL-C) levels decreases stroke recurrence. The aim is to determine the effect of a Mediterranean style diet based on Avocados on lipid profile particularly LDL-C in patients who have had an ischemic stroke and are at high recurrence risk.Methodology: Academic, open-label, blinded outcome assessment (PROBE design), clinical trial. Participants will be patients with an acute ischemic stroke admitted to Clínica Alemana de Santiago, who fulfills the eligibility criteria. Eligible patients will be randomly assigned to either diet intervention in a 1:1 ratio. The interventions will be: A) Avocado based Mediterranean diet with intake of ½ portion of a Hass avocado per day and B) Standard recommendation of low fat-high complex carbohydrate diet recommended by the National Cholesterol Education Program and the American Heart Association. The main efficacy outcome will be the level of plasma LDL-C level at 3 months of the dietary intervention. Secondary outcomes will be changes in: Levels of serum lipid profile, serum inflammation markers, glycemic control, anthropomorphic measures, stroke recurrence, cardiovascular events, adverse events, compliance. A sample size of 100 patients per group (200 in total) was estimated to provide 80% power and 5% level of significance with 10% loss and 5% crossover to detect the same difference in LDL-C after 3 months of intervention in patients with acute stroke. The investigators hypothesize that an Avocado based Mediterranean diet will significantly reduce levels of LDL-cholesterol at 3 months in patients who have suffered a recent acute ischemic stroke compared to the standard diet.

Conditions

• Stroke, Acute
• Stroke, Ischemic

Interventions

OTHER

Avocado-Mediterranean Diet

Mediterranean diet including 1/2 portion of Hass avocado per day, considering a minimum 35% of calories as fat (22% MUFA fat, 6% PUFA fat, and ±10% saturated fat), 15% proteins, and a maximum of 50% carbohydrates.

OTHER

Control-Group Diet

A low fat-high complex carbohydrate diet, during 3 months.

Sponsors & Collaborators

• Comisión Nacional de Investigación Científica y Tecnológica

  collaborator OTHER_GOV

• Clinica Alemana de Santiago

  lead OTHER

Principal Investigators

• Veronica Olavarria, MD · Clinica Alemana de Santiago

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-16

Primary Completion

2023-01-19

Completion

2023-01-19

Countries

• Chile

Study Locations