MIND Diet Intervention to Prevent Alzheimer's Disease

这个R01应用程序“意念饮食干预预防阿尔茨海默病”是第三阶段的随机试验 一项旨在测试地中海和短跑混合体为期3年干预效果的对照试验 在600名65岁以上没有认知障碍的人中，饮食被称为Mind 超重，饮食也不太理想。建议的心灵饮食(地中海-DASH干预 神经退行性延迟)是地中海饮食和DASH饮食的混合体，但有选择的修改 基于饮食痴呆症领域最令人信服的证据。心灵食谱有相同的基本原理 DASH和地中海饮食的组成部分，如强调天然植物性食物和有限的 动物性和高饱和脂肪食物，但独特的是绿叶蔬菜和浆果以及食物 反映营养-痴呆症证据的成分服务。有大量证据表明 流行病学、动物和实验室研究，将饮食与大脑健康联系起来。因此，该字段已为 进行大规模预防试验，以确定饮食和AD预防之间的因果关系。 建立这种关系将极大地影响公众健康，并为许多人提供可信度或驳斥 声称各种食物和饮食模式对阿尔茨海默病有保护作用。饮食指南可以是 由试验发展而来，用于临床实践，向患者提供疾病预防方面的信息。建议数 混合饮食干预对大多数原发性阿尔茨海默病的防治效果 高血压和糖尿病等危险因素以及抑制两大潜在机制 阿尔茨海默病、氧化应激和炎症。该试验将采用平行分组设计，比较以下两种药物的效果 心理干预饮食加轻度热量控制减肥对对照饮食的认知结果， 通常的饮食，温和的热量限制，以减肥。智力饮食的生物学效应将通过以下方式进行评估 对随机选择的300名参与者的大脑宏观和微观结构完整性进行测量。其他 生化标记物将在600名参与者的整个队列中进行评估，包括：血浆Abeta 42/Aβ40、脑源性神经营养因子和血浆氧化应激标志物 发炎。此外，试验将检查潜在的影响调节剂和修饰剂，通过一些 心血管危险因素、阿尔茨海默病生物标志物和生物学机制。这项拟议的研究有两项临床研究 站点，一个在芝加哥(拉什大学)，一个在波士顿(哈佛大学)，以及用于 数据协调和分析(布里格姆妇女医院)、神经成像分析(拉什大学)和 组织生化分析的专门实验室。

This R01 application, “MIND Diet Intervention to Prevent Alzheimer Disease,” is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant-based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition-dementia evidence. There is a substantial body of evidence from epidemiological, animal and laboratory studies to link diet to brain health. Thus, the field is primed for the conduct of a large-scale prevention trial to establish a causal relation between diet and AD prevention. Establishing such a relation would greatly impact the public health and provide credibility to or refute numerous claims that various foods and dietary patterns are protective against AD. Dietary guidelines could be developed from the trial for use in clinical practice to inform patients about disease prevention. The proposed hybrid diet intervention has demonstrated effects on the prevention and treatment of most of the primary AD risk factors such as hypertension and diabetes, and the suppression of the two major underlying mechanisms of AD, oxidative stress and inflammation. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, the trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms. The proposed study has two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham & Women’s Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.