1. Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial.
- Author
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Olavarría VV, Campodónico PR, Vollrath V, von Geldern P, Velásquez C, Pavez P, Valente B, Donoso P, Ginesta A, Cavada G, Mazzon E, Navia V, Guzmán M, Brinck P, Gallardo A, Gonzalez P, and Lavados PM
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Pilot Projects, Diet, Fat-Restricted, Lipids blood, Prospective Studies, Diet, Mediterranean, Persea, Secondary Prevention methods, Ischemic Stroke prevention & control, Ischemic Stroke blood, Ischemic Stroke diet therapy, Cholesterol, LDL blood
- 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., Competing Interests: Declarations. Ethics approval and consent to participate: Ethics approval was obtained from Universidad del Desarrollo, Clínica Alemana de Santiago Scientific Ethics Committee (ID 2018–43) for the first protocol and its amendments. All patients or their next of kin provided written informed consent to participate in the trial. Consent for publication: Not applicable. Competing interests: VO reports receiving research funding from Clínica Alemana de Santiago and ANID-Fondecyt Regular 1181333 during the conduct of the study and a research grant from Boehringer Ingelheim for the RECCA registry outside the submitted work.PL reports research support from Clínica Alemana and Boehringer Ingelheim. Research grants from Clínica Alemana de Santiago during the conduct of the study, personal fees from Boehringer Ingelheim, and a Chilean Government research grant (ANID) for the ÑANDU project outside the submitted work. VN reports receiving an educational grant from Boehringer Ingelheim. PC, VV, PvG, CV, PP, BV, PD, AG, GC, EM, MG, and PB report no conflicts of interest., (© 2025. The Author(s).)
- Published
- 2025
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