Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial

Abstract Background The impact of a healthy diet on the secondary prevention of ischemic stroke (IS) remains uncertain. Levels of low-density lipoprotein cholesterol (LDL-C) are inversely associated with the risk of IS recurrence. A Mediterranean diet (MeDi), consisting of a preference for fish/poul...

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Main Authors: Verónica V. Olavarría, Paola R. Campodónico, Valeska Vollrath, Paula von Geldern, Carolina Velásquez, Patricia Pavez, Barbara Valente, Pamela Donoso, Alexandra Ginesta, Gabriel Cavada, Enrico Mazzon, Víctor Navia, Matías Guzmán, Pablo Brinck, Andrés Gallardo, Pablo Gonzalez, Pablo M. Lavados
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Language:English
Published: BMC 2025-02-01
Series:Lipids in Health and Disease
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Online Access:https://doi.org/10.1186/s12944-025-02454-4
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author Verónica V. Olavarría
Paola R. Campodónico
Valeska Vollrath
Paula von Geldern
Carolina Velásquez
Patricia Pavez
Barbara Valente
Pamela Donoso
Alexandra Ginesta
Gabriel Cavada
Enrico Mazzon
Víctor Navia
Matías Guzmán
Pablo Brinck
Andrés Gallardo
Pablo Gonzalez
Pablo M. Lavados
author_facet Verónica V. Olavarría
Paola R. Campodónico
Valeska Vollrath
Paula von Geldern
Carolina Velásquez
Patricia Pavez
Barbara Valente
Pamela Donoso
Alexandra Ginesta
Gabriel Cavada
Enrico Mazzon
Víctor Navia
Matías Guzmán
Pablo Brinck
Andrés Gallardo
Pablo Gonzalez
Pablo M. Lavados
author_sort Verónica V. Olavarría
collection DOAJ
description Abstract Background The impact of a healthy diet on the secondary prevention of ischemic stroke (IS) remains uncertain. Levels of low-density lipoprotein cholesterol (LDL-C) are inversely associated with the risk of IS recurrence. A Mediterranean diet (MeDi), consisting of a preference for fish/poultry, monosaturated fats from olive oil, fruit, vegetables, whole grains, legumes/nuts and limited red meats, animal fats and sweetened beverages, reduces metabolic syndrome, LDL-C levels and stroke risk. Avocados also reduce metabolic syndrome and LDL-C levels but are not part of the traditional MeDi diet. The effects of an avocado-based Mediterranean diet on LDL-C were investigated and compared to those of a low-fat diet in patients with previous IS. Methods The Avocado-Based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke (ADD-SPISE) was a prospective, randomized, open-label, blinded outcome assessment, phase 2, clinical trial. The participants were adults with an IS in the previous month who were randomly assigned at a 1:1 ratio to a MeDi or a low-fat diet for three months. Outcome assessors of laboratory results and data analysts were masked. The primary outcome was the mean difference in LDL-C between groups at 90 days, adjusted by statin use. Safety, feasibility and acceptability (assessed through a 14-item questionnaire administered to all patients who completed the follow-up) were also evaluated. Results From August 2018 to October 2022, 200 participants were enrolled (97 randomized to the low-fat diet and 103 to the MeDi), with 189 (94.5%) completing the study. There were no significant differences in LDL-C levels between the MeDi group and the low-fat group at 90 days: 66.5 mg/dL (95% confidence interval [CI] 59.6, 73.4) in the MeDi group and 69.9 mg/dL (62.6, 77.2) in the low-fat group at the end of follow-up. The adjusted difference was − 3.4 mg/dL (-13.4, -6.62); P = 0.50. The intervention group showed significant improvements in Mediterranean diet adherence (P < 0.01). Moreover, no significant differences in adverse events were observed between the groups. Conclusion Compared with a low-fat diet, the avocado-based MeDi did not significantly lower LDL-C in IS patients after three months. The intervention was safe, feasible, and well accepted. Larger trials should establish whether longer dietary interventions could yield clinically significant benefits in these patients. The study is registered under ADD-SPISE at www.clinicaltrials.gov . Identifier: NCT03524742.
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spelling doaj-art-9da0fc5c40094012b135142890b258102025-02-09T12:52:39ZengBMCLipids in Health and Disease1476-511X2025-02-0124111210.1186/s12944-025-02454-4Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trialVerónica V. Olavarría0Paola R. Campodónico1Valeska Vollrath2Paula von Geldern3Carolina Velásquez4Patricia Pavez5Barbara Valente6Pamela Donoso7Alexandra Ginesta8Gabriel Cavada9Enrico Mazzon10Víctor Navia11Matías Guzmán12Pablo Brinck13Andrés Gallardo14Pablo Gonzalez15Pablo M. Lavados16Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloCentro de Química Médica, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina, Clínica Alemana, Universidad del DesarrolloLaboratorio Clínico de Clínica Alemana de SantiagoEscuela de Nutrición y Dietética, Facultad de Medicina y Ciencias de la Salud, Universidad MayorUnidad de Investigación y Ensayos Clínicos, Departamento de Desarrollo Académico e Investigación, Clínica Alemana de SantiagoServicio de Alimentación, Hospital Clínico Félix Bulnes CerdaEscuela de Nutrición y Dietética, Facultad de Medicina y Ciencias de la Salud, Universidad MayorMutual de Seguridad y Asesorías S.A.Servicio de Gastroenterología, Departamento de Medicina Interna, Hospital Padre Hurtado, Servicio de Salud Metropolitano Sur OrienteUnidad de Investigación y Ensayos Clínicos, Departamento de Desarrollo Académico e Investigación, Clínica Alemana de SantiagoUnidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloUnidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloUnidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloUnidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloUnidad de TeleACV, Departamento de Salud Digital, Ministerio de Salud. Unidad de Imagenología Compleja, Hospital Carlos Van BurenServicio de Neurología Adultos, Hospital Biprovincial Quillota Petorca, Servicio de Salud Viña del Mar- QuillotaUnidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del DesarrolloAbstract Background The impact of a healthy diet on the secondary prevention of ischemic stroke (IS) remains uncertain. Levels of low-density lipoprotein cholesterol (LDL-C) are inversely associated with the risk of IS recurrence. A Mediterranean diet (MeDi), consisting of a preference for fish/poultry, monosaturated fats from olive oil, fruit, vegetables, whole grains, legumes/nuts and limited red meats, animal fats and sweetened beverages, reduces metabolic syndrome, LDL-C levels and stroke risk. Avocados also reduce metabolic syndrome and LDL-C levels but are not part of the traditional MeDi diet. The effects of an avocado-based Mediterranean diet on LDL-C were investigated and compared to those of a low-fat diet in patients with previous IS. Methods The Avocado-Based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke (ADD-SPISE) was a prospective, randomized, open-label, blinded outcome assessment, phase 2, clinical trial. The participants were adults with an IS in the previous month who were randomly assigned at a 1:1 ratio to a MeDi or a low-fat diet for three months. Outcome assessors of laboratory results and data analysts were masked. The primary outcome was the mean difference in LDL-C between groups at 90 days, adjusted by statin use. Safety, feasibility and acceptability (assessed through a 14-item questionnaire administered to all patients who completed the follow-up) were also evaluated. Results From August 2018 to October 2022, 200 participants were enrolled (97 randomized to the low-fat diet and 103 to the MeDi), with 189 (94.5%) completing the study. There were no significant differences in LDL-C levels between the MeDi group and the low-fat group at 90 days: 66.5 mg/dL (95% confidence interval [CI] 59.6, 73.4) in the MeDi group and 69.9 mg/dL (62.6, 77.2) in the low-fat group at the end of follow-up. The adjusted difference was − 3.4 mg/dL (-13.4, -6.62); P = 0.50. The intervention group showed significant improvements in Mediterranean diet adherence (P < 0.01). Moreover, no significant differences in adverse events were observed between the groups. Conclusion Compared with a low-fat diet, the avocado-based MeDi did not significantly lower LDL-C in IS patients after three months. The intervention was safe, feasible, and well accepted. Larger trials should establish whether longer dietary interventions could yield clinically significant benefits in these patients. The study is registered under ADD-SPISE at www.clinicaltrials.gov . Identifier: NCT03524742.https://doi.org/10.1186/s12944-025-02454-4Ischemic strokeSecondary preventionMediterranean dietAvocadoLDL cholesterol
spellingShingle Verónica V. Olavarría
Paola R. Campodónico
Valeska Vollrath
Paula von Geldern
Carolina Velásquez
Patricia Pavez
Barbara Valente
Pamela Donoso
Alexandra Ginesta
Gabriel Cavada
Enrico Mazzon
Víctor Navia
Matías Guzmán
Pablo Brinck
Andrés Gallardo
Pablo Gonzalez
Pablo M. Lavados
Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
Lipids in Health and Disease
Ischemic stroke
Secondary prevention
Mediterranean diet
Avocado
LDL cholesterol
title Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
title_full Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
title_fullStr Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
title_full_unstemmed Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
title_short Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial
title_sort efficacy of an avocado based mediterranean diet on serum lipids for secondary prevention after ischemic stroke a randomized phase 2 controlled pilot trial
topic Ischemic stroke
Secondary prevention
Mediterranean diet
Avocado
LDL cholesterol
url https://doi.org/10.1186/s12944-025-02454-4
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