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Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol
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 c...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213277/ https://www.ncbi.nlm.nih.gov/pubmed/34128908 http://dx.doi.org/10.1097/MD.0000000000026425 |
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author | Olavarría, Verónica V. Campodónico, Paola Vollrath, Valeska von Geldern, Paula Velásquez, Carolina Pavez, Patricia Valente, Barbara Donoso, Pamela Ginesta, Alexandra Cavada, Gabriel Mazzon, Enrico Navia, Víctor Guzmán, Matías Brinck, Pablo Lavados, Pablo M. |
author_facet | Olavarría, Verónica V. Campodónico, Paola Vollrath, Valeska von Geldern, Paula Velásquez, Carolina Pavez, Patricia Valente, Barbara Donoso, Pamela Ginesta, Alexandra Cavada, Gabriel Mazzon, Enrico Navia, Víctor Guzmán, Matías Brinck, Pablo Lavados, Pablo M. |
author_sort | Olavarría, Verónica V. |
collection | PubMed |
description | 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. PATIENTS AND METHODS: 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 3 months 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 4.6 mg/dL in LDL-C after 3 months 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). |
format | Online Article Text |
id | pubmed-8213277 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-82132772021-06-21 Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol Olavarría, Verónica V. Campodónico, Paola Vollrath, Valeska von Geldern, Paula Velásquez, Carolina Pavez, Patricia Valente, Barbara Donoso, Pamela Ginesta, Alexandra Cavada, Gabriel Mazzon, Enrico Navia, Víctor Guzmán, Matías Brinck, Pablo Lavados, Pablo M. Medicine (Baltimore) 5300 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. PATIENTS AND METHODS: 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 3 months 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 4.6 mg/dL in LDL-C after 3 months 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). Lippincott Williams & Wilkins 2021-06-18 /pmc/articles/PMC8213277/ /pubmed/34128908 http://dx.doi.org/10.1097/MD.0000000000026425 Text en Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) |
spellingShingle | 5300 Olavarría, Verónica V. Campodónico, Paola Vollrath, Valeska von Geldern, Paula Velásquez, Carolina Pavez, Patricia Valente, Barbara Donoso, Pamela Ginesta, Alexandra Cavada, Gabriel Mazzon, Enrico Navia, Víctor Guzmán, Matías Brinck, Pablo Lavados, Pablo M. Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title | Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title_full | Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title_fullStr | Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title_full_unstemmed | Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title_short | Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol |
title_sort | effects of an avocado-based mediterranean diet on serum lipids for secondary prevention after ischemic stroke trial (add-spise): study protocol |
topic | 5300 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213277/ https://www.ncbi.nlm.nih.gov/pubmed/34128908 http://dx.doi.org/10.1097/MD.0000000000026425 |
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