基于鳄梨的地中海饮食对缺血性中风后二级预防的血脂影响试验（ADD-SPISE）：研究方案。

Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol.

机构信息

Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría.

Departamento de Paciente Crítico, Clínica Alemana de Santiago.

出版信息

Medicine (Baltimore). 2021 Jun 18;100(24):e26425. doi: 10.1097/MD.0000000000026425.

DOI:10.1097/MD.0000000000026425

PMID:34128908

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8213277/

Abstract

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).

摘要

背景

不良或不健康的饮食是导致缺血性中风风险的重要因素。遵循饮食模式，如富含单不饱和脂肪酸的地中海饮食，主要来自橄榄油，与较低的中风风险相关。此外，降低低密度胆固醇（LDL-C）水平可减少中风复发。有趣的是，鳄梨替代饮食也富含单不饱和脂肪酸，可显著降低 LDL 胆固醇水平。本研究旨在评估在最近发生急性缺血性中风的患者中，与低脂高复合碳水化合物饮食相比，基于鳄梨的地中海饮食在干预 3 个月后是否能降低 LDL-C。该试验还将评估安全性和可行性。

患者和方法

前瞻性、随机、开放标签、盲法结局评估临床试验。参与者为发病后一个月内入院的缺血性中风患者，同意并符合入选标准。患者按 1:1 的比例随机分配到两种饮食干预组，在常规二级预防治疗的基础上进行干预。干预饮食为：A). 每天摄入半份鳄梨的鳄梨为基础的地中海饮食，B). 对照组饮食为低脂高复合碳水化合物饮食。主要疗效结局为饮食干预 3 个月后血浆 LDL-C 水平的降低。次要结局包括血脂谱和血清炎症标志物水平的变化、安全性和可行性。估计需要 200 例患者，以提供 80%的功效和 5%的显著性水平（10%的损失和 5%的交叉），以检测 3 个月后 LDL-C 降低至少 4.6mg/dL。