Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Change in a composite global cognition score
研究概览
简要总结
By doing this study, researchers hope to learn how the Mediterranean and low-fat eating patterns affect memory, brain volume, brain antioxidant status and cardio-metabolic biomarkers, such as blood pressure and blood glucose, in cognitively normal older adults. Researchers also plan to examine underlying processes relating the patterns to brain health.
详细描述
Participants will be randomized to either a Mediterranean or low-fat eating pattern. Participation in the study will last about 13 months. Each person will be prescribed one of two eating patterns for 12 months. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian. Participants will engage in monthly food demonstrations and cooking classes. Participants will pick up a bag of food items belonging to the prescribed eating pattern, on a weekly basis for 6 months, from a local grocery store chain.
Participants have the option to continue in the study for up to 2 years for additional measurements.
Potential participants need to be located within the Kansas City metro area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Raters - (psychometrician, brain magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DEXA), and phlebotomy) will be blinded to the intervention group and will perform outcome assessments.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitively normal older adults ≥65 years (MMSE score ≥ 25; AD8 score of 2 or less; no prior diagnosis of MCI, AD or dementia; and not medically treated for cognitive impairment or dementia)
- •Speak English as a primary language
- •Be able to read and write in English
- •Live in the Kansas City, Metropolitan area
- •Body Mass Index (BMI) range between 20 - 40 kg/m2
排除标准
- •Serious medical risk, such as type 1 diabetes mellitus, cancer, recent cardiac event (e.g. heart attach, angioplasty)
- •Taking the prescription drug Warfarin
- •Taking a prescription fish oil, such as Lovaza, Omtryga, Vascepa, Epanova, etc., or prescribed a dose of over-the-counter (OTC) fish oil containing ≥300 mg Docohexanoic Acid (DHA) that cannot be adjusted to a lower dose
- •Nut allergy, fish allergy (does not include shellfish)
- •Adherence to specialized diet regimes (e.g., vegan, bariatric, renal, etc.) that make following either of the dietary plans impossible or unsafe
- •Unwilling to be randomized to one of two diet interventions
- •Evidence of severe major depression (GDS-SF ≥9) or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures
- •Alcohol (over 3 drinks per day or total of 18 per week) or drug abuse, defined as the use of chemical substances (prescription, OTC or illegal drugs) in a pattern that can lead to an increased risk of problems and an inability to control the use of the substance
- •Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, retirement community with reliance on dining facilities for meals)
- •Already consuming a Mediterranean diet as determined using the 14-item MedD Assessment Tool (score of ≥8)
- •Already consuming a low-fat diet as determined by the NCI Percentage Energy from Fat Screener (≤ 15% of calories from fat)
- •Already participating in another research study
- •Another member of household is already participating in this study
- •Have a visual impairment that greatly diminishes ability to read or write
- •Currently attempting to lose weight
结局指标
主要结局
Change in a composite global cognition score
时间窗: Baseline, 6 months and 12 months
Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and NIH Toolbox (NIH-TB) Cognition Battery and will be used to assess changes in a composite global cognition score at baseline, 6, and 12 months.
次要结局
- Change in cerebral antioxidant levels(Baseline and 12 months)
- Change in total cholesterol(Baseline and 12 months)
- Change in high sensitivity C-Reactive Protein (hs-CRP)(Baseline and 12 months)
- Change in Verbal Memory Factor(Baseline, 6 months and 12 months)
- Change in Executive Function Factor(Baseline, 6 months and 12 months)
- Change in percentage of total fatty acids by weight(Baseline and 12 months)
- Change in HDL cholesterol(Baseline and 12 months)
- Change in LDL cholesterol(Baseline and 12 months)
- Change in Trimethylamine N-oxide (TMAO)(Baseline and 12 months)
- Change in blood pressure(Baseline, 6 months and 12 months)
- Change in total/HDL cholesterol ratio(Baseline and 12 months)
- Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)(Baseline and 12 months)
- Change in Hemoglobin A1c (HbA1c)(Baseline and 12 months)
- Change in Verbal Memory Factor post intervention(24 and 36 months)
- Change in Visuospatial Processing Factor(Baseline, 6 months and 12 months)
- Change in triglycerides(Baseline and 12 months)
- Change in insulin resistance score(Baseline and 12 months)
- Change in a composite global cognition score post intervention(24 and 36 months)
- Change in Attention Factor(Baseline, 6 months and 12 months)
- Change in Speed of Processing Factor(Baseline, 6 months and 12 months)
- Change in brain volume(Baseline and 12 months)
- Change in apolipoprotein B(Baseline and 12 months)
- Change in lipoprotein(a) (Lp(a))(Baseline and 12 months)
- Change in fasting glucose(Baseline and 12 months)
- Change in Visuospatial Processing Factor post intervention(24 and 36 months)
- Change in Speed of Processing Factor post intervention(24 and 36 months)
- Change in Attention Factor post intervention(24 and 36 months)
- Change in Executive Function Factor post intervention(24 and 36 months)
- Measure of dietary adherence post intervention(24 and 36 months)
研究者
Debra K. Sullivan, PhD, RD
Chair and Endowed Professor of Clinical Nutrition
University of Kansas Medical Center