Enhanced Mediterranean Diet for Alzheimer's Disease Prevention

项目摘要/摘要 阿尔茨海默病(AD)现在是美国最昂贵的疾病，比癌症和心脏病更昂贵 疾病。如果没有有效的治疗方法来减缓或阻止这种疾病，人们越来越重视发展 方法预防和延缓发病。观察数据和有限的临床试验证据表明， 地中海饮食可能会延缓与年龄相关的认知能力下降，延缓或预防AD的发生。那里 仍然需要严格的数据来证明它的有效性，并开发出在 提高采用率和遵从性的方式。我们有良好的业绩记录，严格执行 饮食干预，包括最近的地中海饮食试点试验。我们已经建立了一些方法来 提供干预措施，并有数据表明我们可以成功地教育老年人收养和 坚持地中海饮食模式。我们的Med O套餐包括正规教育和咨询，每天 橄榄油、杏仁和omega-3脂肪酸的处方，以及通过与 一家大型食品杂货连锁店。我们现在建议测试这种高度可扩展和可重现的管理方法 Med O饮食在一项随机试验中测试其与低脂(对照)饮食对认知改变的有效性 1岁以上的老年人(n=200名男性和女性≥65岁)。主端点比较平均值 12个月时节食前后综合全球认知评分的变化。其他成果包括 记忆、执行和视觉空间功能的二级综合指数。目标2决定Med O如何 影响大脑体积和大脑抗氧化系统(谷胱甘肽和维生素C)。目标3探讨了 Med O对心脏代谢标志物(血压、血糖、糖化血红蛋白、胰岛素、高级血脂、C- 反应蛋白和脂蛋白相关磷脂酶A2)。AIM 4包含在电子统计模拟中 这将决定一项更大规模的多点试验的最有效的方法和结果。这样做的结果 该项目将具有重要的

Project Summary/Abstract Alzheimer's disease (AD) is now America's most expensive disease, more costly than cancer and heart disease. Without effective therapies to slow or stop the disease, there is an increasing emphasis on developing methods to prevent and delay the onset. Observational data, and limited clinical trial evidence, suggest that the Mediterranean diet may slow age-related cognitive decline and delay or prevent the onset of AD. There remains a need for rigorous data proving its effectiveness and to develop methods for delivering the diet in a way that enhances adoption and adherence. We have a demonstrated track record of performing rigorous dietary interventions, including a recent pilot Mediterranean diet trial. We have established methods for delivering the intervention and have data indicating we can successfully educate older adults to adopt and adhere to a Mediterranean diet pattern. Our Med+O package includes formal education and counseling, daily prescriptions for olive oil, almonds, and omega-3 fatty acids, and a weekly food box through a partnership with a major grocery chain. We now propose to test this highly scalable and reproducible approach to administering the Med+O diet in a randomized trial testing its effectiveness versus a low fat (control) diet on cognitive change over 1 year in older adults (n = 200 men and women ≥ 65 years). The primary endpoint compares the mean change in pre and post-diet composite global cognition score at 12 months. Additional outcomes include secondary composite indices of memory, executive, and visuospatial function. Aim 2 determines how Med+O impacts brain volume and cerebral antioxidant systems (glutathione and vitamin C). Aim 3 explores the impact of Med+O on cardiometabolic markers (blood pressure, glucose, HbA1c, insulin, advanced lipid testing, C- reactive protein and Lipoprotein-associated phospholipase A2). Aim 4 includes in silico statistical simulations that will determine the most impactful methods and outcomes for a larger, multi-site trial. The results of this project will have important