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

Stroke, Acute Clinical Trial

— ADD-SPISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524742
• Other study ID #: ADD-SPISE trial
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: January 19, 2023

Study information

• Verified date: August 2023
• Source: Clinica Alemana de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction: Stroke is the second cause of death and the third of years of life lost worldwide. In Chile, stroke is the second cause of death. Ischemic stroke represents roughly 80% of all strokes. The 11 risk factors responsible for 91.8% of the population attributable risk of ischemic stroke are: Age, Blood Pressure ≥140/90mmHg, smoking, waist to hip ratio, Diabetes Mellitus, physical activity, alcohol intake, psychosocial factors, Apo-lipoproteins, Cardiac causes and noteworthy a healthy diet (35.8% of the population attributable risk). Recent global burden of disease analysis of disability adjusted life years (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 mono unsaturated fatty acids (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 very little information of what patients eat before or after an ischemic stroke. Recurrent stroke represent 20% of all ischemic strokes at a population level and depending on the etiology, recurrent stroke can occur from 2 to 20% at 3 months of the initial event. Lowering Low Density Cholesterol (LDL-C) levels decreases stroke recurrence.

Goals: The aim is to determine the effect of a Mediterranean style diet based on Avocados as a source of poli unsaturated fatty acids (PUFAs) 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 (prospective, randomized, open-blinded end-point [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 cholesterol 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 of the metabolic syndrome, 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 following measurements will be performed at baseline and at 3 months in all patients: Blood pressure, weight, height, waist circumference, cholesterol and triglyceride levels, glucose level, serum insulin level, Apo- lipoproteins A1 and B levels, soluble intercellular adhesion molecule-1, vascular cell adhesion molecule-1, Apo lipoproteins A and B, and interleukin-6 levels; In a random sample of participants (35%), investigators will measure the oleic acid plasma content as a measure of adherence to Avocado intake.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Age = 45 years.

2. A recent ischemic stroke (within the past month).

3. 1 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.

4. Informed consent provided.

Exclusion Criteria:

1. Comorbidities that would interfere with compliance of the interventions or low likelihood of changing dietary habits (ie, oncological diseases under chemotherapy, institutionalized patients).

2. Known allergy to avocados.

3. Any feeding limitation that could interfere with the dietary intervention such as dysphagia.

4. Mandatory use drugs for other reasons that can change lipid profile (like hormonal therapy, antiretroviral therapy, chronic steroids etc.).

5. 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.

6. Any concomitant illness with life expectancy of less than 3 months or that would interfere with the outcome assessments and/or follow-up.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

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.
• Control-Group Diet
A low fat-high complex carbohydrate diet, during 3 months.

Locations

Country	Name	City	State
Chile	Clinica Alemana de Santiago	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Alemana de Santiago	Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol level	Low Density Lipoprotein (LDL) cholesterol level in mg/dL level at 3 months of the dietary intervention.	3 months
Secondary	Levels of total cholesterol	Total cholesterol level in mg/dL at 3 months of dietary intervention	3 months
Secondary	HDL Cholesterol level	High Density Lipoprotein (HDL) cholesterol level in mg/dL level at 3 months of the dietary intervention.	3 months
Secondary	Triglycerides level	Triglycerides level in mg/dL level at 3 months of the dietary intervention.	3 months
Secondary	Systolic blood pressure	Mean systolic blood pressure in mmHg	3 months
Secondary	Waist to hip ratio	Measure of waist diameter in centimeters and hip diameter in centimeters to report waist to hip ratio	3 months
Secondary	Body mass index	Weight in kilograms and height in meters will be combined to report body mass index in kg/m^2	3 months
Secondary	Serious adverse events	Frequency of serious adverse events	3 months
Secondary	Stroke Recurrence	Frequency of stroke recurrence	3 months
Secondary	Frequency of major cardiovascular events	Frequency of major cardiovascular events (composed by acute myocardial infarction, stroke or vascular death).	3 months
Secondary	ICAM serum level	ICAM (intercelular adhesion molecule) in ng/mL	3 months
Secondary	Interleukin-6 serum level	Level of Interleukin-6 in ng/mL	3 months
Secondary	Apolipoproteins levels A and B	Level of Apolipoporoteins A and B in g/L	3 months
Secondary	VCAM serum level	VCAM (vascular cell adhesion molecule) in ng/mL	3 months
Secondary	Determine plasma oleic acid levels in a subgroup	Measurement of plasma oleic acid levels compared to basal in a randomized sample of 35% of group randomized to avocado based mediterranean diet	3 months