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

NCT03524742 | Completed

• 1 other identifier: ADD-SPISE trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diet; Cholesterol

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol level

  Low Density Lipoprotein (LDL) cholesterol level in mg/dL level at 3 months of the dietary intervention.

  3 months

Secondary Outcomes (14)

• Levels of total cholesterol

  3 months

• HDL Cholesterol level

  3 months

• Triglycerides level

  3 months

• Systolic blood pressure

  3 months

• Waist to hip ratio

  3 months

Study Arms (2)

Avocado-Mediterranean Diet

EXPERIMENTAL

Avocado based Mediterranean diet with intake of ½ portion of a Hass avocado per day, during 3 months.

Other: Avocado-Mediterranean Diet

Control-Group Diet

ACTIVE COMPARATOR

Control-Group Diet consists of a low fat-high complex carbohydrate diet, during 3 months.

Other: Control-Group Diet

Interventions

Avocado-Mediterranean Diet OTHER

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.

Avocado-Mediterranean Diet

Control-Group Diet OTHER

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

Control-Group Diet

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years.
• A recent ischemic stroke (within the past month).
• or more of the following cardiovascular risk factor: hypertension, type 2 diabetes mellitus, insulin resistance, dyslipidemia (elevated LDL or total cholesterol), current tobacco use, coronary heart disease, body mass index ≥25, family history of premature CVD.
• Informed consent provided.

You may not qualify if:

• Comorbidities that would interfere with compliance of the interventions or low likelihood of changing dietary habits (ie, oncological diseases under chemotherapy, institutionalized patients).
• Known allergy to avocados.
• Any feeding limitation that could interfere with the dietary intervention such as dysphagia.
• Mandatory use drugs for other reasons that can change lipid profile (like hormonal therapy, antiretroviral therapy, chronic steroids etc.).
• The following ischemic stroke possible etiologies without any of the above mentioned cardiovascular risk factors: arterial dissection, thrombophilia, cerebral vasoconstriction reversible syndrome, other infrequent or rare causes such as vasculitis or stroke related to autoimmune diseases.
• Any concomitant illness with life expectancy of less than 3 months or that would interfere with the outcome assessments and/or follow-up.

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Olavarria VV, Campodonico PR, Vollrath V, von Geldern P, Velasquez C, Pavez P, Valente B, Donoso P, Ginesta A, Cavada G, Mazzon E, Navia V, Guzman M, Brinck P, Gallardo A, Gonzalez P, Lavados PM. Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial. Lipids Health Dis. 2025 Feb 4;24(1):37. doi: 10.1186/s12944-025-02454-4.

  PMID: 39905430 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Veronica Olavarria, MD

  Clinica Alemana de Santiago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: open-label, blinded outcome assessment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Academic, open-label, blinded outcome assessment (PROBE design), clinical trial.

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 15, 2018
• Study Start: August 16, 2018
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)