Enhanced Mediterranean Diet for Alzheimer's Disease Prevention

强化地中海饮食预防阿尔茨海默病

• 批准号: 10177834
• 负责人: JEFFREY Murray BURNS
• 金额: $ 71.05万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10177834
• 关键词: Adherence; Adopted; Adoption; Affect; Age of Onset; Age-associated memory impairment; Alcohols; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; American; Americas; Antioxidants; Ascorbic Acid; Attenuated; Behavior; Biological Markers; Blood Pressure; C-reactive protein; Cardiovascular system; Cerebrum; Clinical Trials; Cognition; Cognitive; Cognitive aging; Consumption; Counseling; Data; Dementia; Development; Diabetes Mellitus; Diet; Dietary Intervention; Disease; Education; Effectiveness; Elderly; Fabaceae; Fatty acid glycerol esters; Fishes; Food; Food Patterns; Fruit; Glucose; Glutathione; Glycosylated hemoglobin A; Goals; Heart Diseases; Impaired cognition; Individual; Insulin; Intervention; Life Style; Lipids; Magnetic Resonance Spectroscopy; Malignant Neoplasms; Measures; Meat; Mediterranean Diet; Memory; Metabolic; Methods; Monte Carlo Method; Nutrient; Nuts; Olive oil preparation; Omega-3 Fatty Acids; Outcome; Oxidative Stress; Participant; Pattern; Public Health; Public Sector; Randomized; Randomized Controlled Trials; Reproducibility; Risk; Risk Factors; Sample Size; System; Testing; Time; Translations; Vegetables; Visuospatial; Wine; Woman; age related; aging brain; brain health; brain volume; cardiometabolism; cerebral atrophy; cognitive benefits; cognitive change; cost; dementia risk; design; diet and exercise; dietary control; effective therapy; efficacy trial; experience; fruits and vegetables; hippocampal atrophy; improved; in silico; indexing; ineffective therapies; lipoprotein-associated phospholipase A(2); men; multi-site trial; pilot trial; population based; prevent; primary endpoint; primary outcome; processing speed; randomized trial; saturated fat; simulation; standard of care

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

项目总结/摘要 阿尔茨海默氏病（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疾病， 预防和延迟发病的方法。观察数据和有限的临床试验证据表明， 地中海饮食可以减缓与年龄相关的认知能力下降，延缓或预防AD的发病。那里 仍然需要严格的数据来证明其有效性，并开发出以 提高采用率和遵守率的方式。我们有一个严格的执行记录， 饮食干预，包括最近的地中海饮食试验。我们已经建立了方法， 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， 坚持地中海饮食模式。我们的Med+O套餐包括每日正规教育和咨询 橄榄油，杏仁和欧米茄-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伸缩和可复制的方法， 在一项随机试验中，Med+O饮食与低脂（对照）饮食相比，在认知变化方面的有效性 1年以上的老年人（n = 200例男性和女性≥ 65岁）。主要终点比较平均值 12个月时饮食前后综合整体认知评分的变化。其他成果包括 记忆、执行和视觉空间功能的次级复合指数。目标2确定Med+O 影响脑容量和大脑抗氧化系统（谷胱甘肽和维生素C）。目标3探索影响 Med+O对心脏代谢标志物（血压、血糖、HbA 1c、胰岛素、高级血脂检测、C- 反应蛋白和脂蛋白相关磷脂酶A2）。目标4包括计算机统计模拟 这将为更大规模的多中心试验确定最有效的方法和结果。的结果 项目将具有重要的