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

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ClinicalTrials.gov Identifier: NCT03524742
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Veronica Olavarria, Clinica Alemana de Santiago

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Stroke, Ischemic Other: Avocado-Mediterranean Diet Other: Control-Group Diet Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Academic, open-label, blinded outcome assessment (PROBE design), clinical trial.
Masking: Single (Outcomes Assessor)
Masking Description: open-label, blinded outcome assessment
Primary Purpose: Other
Official Title: Effects of an Avocado Based meDiterranean Diet on Serum Lipids for Secondary Prevention After Ischemic StrokE Trial (ADD-SPISE)
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Avocado-Mediterranean Diet
Avocado based Mediterranean diet with intake of ½ portion of a Hass avocado per day, during 3 months.
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.

Active Comparator: Control-Group Diet
Control-Group Diet consists of a low fat-high complex carbohydrate diet, during 3 months.
Other: Control-Group Diet
A low fat-high complex carbohydrate diet, during 3 months.




Primary Outcome Measures :
  1. LDL cholesterol level [ Time Frame: 3 months ]
    Low Density Lipoprotein (LDL) cholesterol level in mg/dL level at 3 months of the dietary intervention.


Secondary Outcome Measures :
  1. Levels of total cholesterol [ Time Frame: 3 months ]
    Total cholesterol level in mg/dL at 3 months of dietary intervention

  2. HDL Cholesterol level [ Time Frame: 3 months ]
    High Density Lipoprotein (HDL) cholesterol level in mg/dL level at 3 months of the dietary intervention.

  3. Triglycerides level [ Time Frame: 3 months ]
    Triglycerides level in mg/dL level at 3 months of the dietary intervention.

  4. Systolic blood pressure [ Time Frame: 3 months ]
    Mean systolic blood pressure in mmHg

  5. Waist to hip ratio [ Time Frame: 3 months ]
    Measure of waist diameter in centimeters and hip diameter in centimeters to report waist to hip ratio

  6. Body mass index [ Time Frame: 3 months ]
    Weight in kilograms and height in meters will be combined to report body mass index in kg/m^2

  7. Serious adverse events [ Time Frame: 3 months ]
    Frequency of serious adverse events

  8. Stroke Recurrence [ Time Frame: 3 months ]
    Frequency of stroke recurrence

  9. Frequency of major cardiovascular events [ Time Frame: 3 months ]
    Frequency of major cardiovascular events (composed by acute myocardial infarction, stroke or vascular death).

  10. ICAM serum level [ Time Frame: 3 months ]
    ICAM (intercelular adhesion molecule) in ng/mL

  11. Interleukin-6 serum level [ Time Frame: 3 months ]
    Level of Interleukin-6 in ng/mL

  12. Apolipoproteins levels A and B [ Time Frame: 3 months ]
    Level of Apolipoporoteins A and B in g/L

  13. VCAM serum level [ Time Frame: 3 months ]
    VCAM (vascular cell adhesion molecule) in ng/mL

  14. Determine plasma oleic acid levels in a subgroup [ Time Frame: 3 months ]
    Measurement of plasma oleic acid levels compared to basal in a randomized sample of 35% of group randomized to avocado based mediterranean diet



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 45 and ≤85 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524742


Contacts
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Contact: Veronica Olavarria, MD 56222101111 ext 1060 volavarria@alemana.cl

Locations
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Chile
Clinica Alemana de Santiago Recruiting
Santiago, Region Metropolitana, Chile
Contact: Veronica V Olavarria, MD       volavarria@alemana.cl   
Sponsors and Collaborators
Clinica Alemana de Santiago
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
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Principal Investigator: Veronica Olavarria, MD Clinica Alemana de Santiago

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Responsible Party: Veronica Olavarria, Principal Investigator, Clinica Alemana de Santiago
ClinicalTrials.gov Identifier: NCT03524742     History of Changes
Other Study ID Numbers: ADD-SPISE trial
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veronica Olavarria, Clinica Alemana de Santiago:
Diet
Cholesterol
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes