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

项目概要/摘要阿尔茨海默病（AD）现在是美国最昂贵的疾病，比癌症和心脏病还要昂贵由于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这种疾病。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能会减缓与年龄相关的认知能力下降，并延缓或预防 AD 的发作。仍然需要严格的数据来证明其有效性，并开发以一种方式提供饮食的方法我们拥有严格执行的记录。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采用和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 omega-3 脂肪酸的处方，以及与以下机构合作的每周食品盒我们现在建议测试这种高度可扩展和可重复的管理方法。 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超过 1 岁的老年人（n = 200 名≥ 65 岁的男性和女性）主要终点比较平均值。 12 个月时饮食前后综合认知评分的变化其他结果包括。记忆、执行和视觉空间功能的二级综合指数目标 2 如何确定 Med+O。影响大脑容量和脑抗氧化系统（谷胱甘肽和维生素 C） Aim 3 探讨了其影响。 Med+O 对心脏代谢标志物（血压、血糖、HbA1c、胰岛素、血脂高级测试、C- 目标 4 包括计算机统计模拟。这将决定更大规模的多地点试验的最有影响力的方法和结果。项目将有重要