Enhanced Mediterranean Diet for Alzheimer's Disease Prevention

强化地中海饮食预防阿尔茨海默病

基本信息

批准号：
9579375
负责人：
JEFFREY Murray BURNS
金额：
$ 75.89万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
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/9579375
关键词：
Adherence Adopted Adoption Affect Age of Onset Age-associated memory impairment Alcohols Alzheimer disease prevention Alzheimer&apos s Disease Alzheimer&apos 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 Computer Simulation 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 design diet and exercise effective therapy efficacy trial experience fruits and vegetables hippocampal atrophy improved 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

项目摘要

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

项目摘要/摘要阿尔茨海默氏病（AD）现在是美国最昂贵的疾病，比癌症和心脏更昂贵疾病。没有有效的疗法来减慢或阻止疾病，越来越重视发展预防和延迟发作的方法。观察数据和有限的临床试验证据表明地中海饮食可能会减慢与年龄相关的认知下降，延迟或阻止AD发作。那里仍然需要严格的数据证明其有效性，并开发用于在增强采用和依从性的方式。我们有一个表现严格的记录饮食干预措施，包括最近的一项试点地中海饮食试验。我们已经建立了提供干预措施并有数据表明我们可以成功教育老年人接受和遵守地中海饮食模式。我们的医学+O包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，以及通过与主要的杂货连锁店。现在，我们建议测试这种管理高度可重复的方法在随机试验中，MED+O饮食测试其有效性与低脂肪（对照）饮食的认知变化老年人超过1年（n = 200名男女≥65岁）。主要终点比较平均 12个月时的前和后综合全球认知评分的变化。其他结果包括内存，执行和视觉功能的次要综合索引。 AIM 2确定MED+O AIM 3探讨了脑体积和脑抗氧化剂系统（谷胱甘肽和维生素C）的影响。心脏代谢标记中的MED+O（血压，葡萄糖，HBA1C，胰岛素，晚期脂质测试，C-）反应性蛋白和脂蛋白相关的磷脂酶A2）。 AIM 4包括在计算机统计模拟中这将确定更大的多站点试验的最有影响力的方法和结果。结果的结果项目将有重要