Effects of an avocado-based mediterranean diet on serum lipids for secondary prevention after ischemic stroke trial (ADD-SPISE) Study protocol
Author
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Olivarría, Verónica V.
Author
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Campodónico, Paola
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Vollrath, Valeska
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Von Geldern, Paula
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Velásquez, Carolina
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Pavez, Patricia
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Valente, Bárbara
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Donoso, Pamela
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Ginesta Frings, Carmen Alexandra
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Cavada, Gabriel
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Mazzon, Enrico
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Navia, Víctor
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Guzmán, Matías
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Brinck, Pablo
Author
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Lavados, Pablo M.
Admission date
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2021-12-07T18:39:13Z
Available date
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2021-12-07T18:39:13Z
Publication date
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2021
Cita de ítem
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Medicine (2021) 100:24
es_ES
Identifier
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10.1097/MD.0000000000026425
Identifier
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https://repositorio.uchile.cl/handle/2250/183111
Abstract
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Background: A poor or unhealthy diet is responsible for an important fraction of ischemic stroke risk. Adherence to dietary
patterns, such as the Mediterranean diet, rich in monounsaturated fatty acids mainly from olive oil, is associated with a lower stroke
risk. Furthermore, lowering low-density cholesterol (LDL-C) levels decreases stroke recurrence. Interestingly, Avocado-substituted
diets, which are also rich in monounsaturated fatty acids, significantly decrease LDL cholesterol levels. This study aims to evaluate
whether a Mediterranean diet based on Avocados reduces LDL-C compared to a low-fat high-complex carbohydrate diet after 3
months of the intervention in patients who had a recent acute ischemic stroke. The trial will also assess safety and feasibility.
Patientsandmethods:Prospective, randomized open-label, blinded outcome assessment clinical trial. Participants are patients
within a month of being admitted with an ischemic stroke, who consent and fulfil the eligibility criteria. Patients are randomly assigned
to either diet intervention in a 1:1 ratio on top of the usual secondary prevention treatment. The intervention diet is:
A) Avocado-based Mediterranean diet with intake of 1/2 portion of Avocado per day and
B) The control diet is a low-fat high-complex carbohydrate diet.
The main efficacy outcome is a reduction in plasma LDL-C levels at 3months of the dietary intervention. Secondary outcomes
include changes in the levels of serum lipid profile and serum inflammation markers, safety, and feasibility. A sample size of 200 patients was estimated to provide 80% power and 5% level of significance (10% loss and 5% crossover) to detect a minimum
difference of 4.6mg/dL in LDL-C after 3months of intervention.
Conclusion: We hypothesize that an Avocado-based Mediterranean diet will further reduce the levels of LDL-cholesterol at 3
months compared to the control diet, and that the intervention is safe and feasible.
Registration: The study is registered under ADDSPISE at www.clinicaltrials.gov. Identifier NCT03524742. Protocol ID CAS-605
version 3.0 (May 2nd, 2019).
Abbreviations: AE = adverse events, BMI = body mass index, HDL-C = high density lipoprotein cholesterol, IS = ischemic stroke,
LDL-C = lowering low-density cholesterol, MEDAS = Mediterranean Diet Adherence Screener, MeDi = Mediterranean Diet, MUFA =
monounsaturated fatty acids, PUFA = polyunsaturated fatty acids, SAE = serious adverse events, TC = total cholesterol.