Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 2
- 主要终点
- Change in Mean Global Composite Cognition Score From Baseline
研究概览
简要总结
This is a pilot randomized controlled clinical trial is designed to investigate whether the Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in Bronx, New York compared to a usual diet.
详细描述
The Multicultural Healthy Diet (MHD) is a pilot randomized controlled clinical trial designed to test the effects of an 18 month intervention on cognitive function among 290 middle-aged individuals (40-65 yr). MHD is an anti-inflammatory diet tailored to a multicultural population. The emphasis of the intervention is on plant-based foods and limited animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participants. The trial will employ a parallel group design comparing the effects of the dietary intervention (MHD) on cognitive status to those of the control diet or usual diet plus modules on self-care matters such as dealing with aches and pains of aging, obtaining a health care proxy ,etc. To show that MHD can be adapted to this population serum biomarkers indicative of the MHD diet pattern such as fatty acid profile as well as other key nutrition biomarkers will be evaluated. Other aims include testing whether the MHD intervention can benefit cognitive function using real-time ambulatory assessments. The investigators will also assess plasma and serum markers of inflammation. Components of the MHD diet that are associated with stable or improved measures of cognition will also be evaluated. The clinical site for the proposed study is at the Albert Einstein College of Medicine; the ambulatory cognitive assessment reading center is at Pennsylvania State University, State College; the statistical core is at the Kaiser Permanente Washington Health Research Institute and the laboratory for biospecimen analysis is at the University of Minnesota.
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
The research clinician who assesses cognitive status needs to be blinded to assignment.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •living, working, attending school or visiting Co-op City, Bronx (e.g. for shopping, doctors' visits, etc.) or communities neighboring Co-op City and between 40-65 yr of age
- •willingness to accept assignment to intervention or comparison diet group
- •willingness to participate in a study where weight loss is not a primary goal
排除标准
- •cognitively impaired
- •history of traumatic brain injury
- •psychiatric illness
- •history of diabetes and experiencing hypoglycemia
- •liver disease
- •uncontrolled hypertension as defined as blood pressure > 140/90 mm Hg
- •history of cardiovascular disease that affects physical functioning
- •severe chronic illness
- •low literacy
- •history of alcohol or drug dependence
- •hematologic disease or malignancy not in remission for more than 5 years
- •visual, auditory, or motor impairment that precludes cognitive testing.
- •chronic kidney disease on dialysis or special diet
结局指标
主要结局
Change in Mean Global Composite Cognition Score From Baseline
时间窗: Baseline (Burst 1) and 9 months (Burst 2)
Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.
次要结局
- Dietary Inflammatory Index (DII) Score(Baseline (Burst 1) and 9 months (Burst 2))
- Energy-Adjusted DII Score(Baseline (Burst 1) and 9 months (Burst 2))
- Total Serum Folate Levels(Baseline (Burst 1) and 9 months (Burst 2))
- α-Tocopherol Levels(Baseline (Burst 1) and 9 months (Burst 2))
- α-Carotenoid Levels(Baseline (Burst 1) and 9 months (Burst 2))
- Vitamin B12 Levels(Baseline (Burst 1) and 9 months (Burst 2))
- Fatty Acid Profile(Baseline (Burst 1) and 9 months (Burst 2))
- Serum Sodium(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Total Moisture(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Energy(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Protein(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Total Fats(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Carbohydrates(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Total Folate From Food(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Non-food Folate(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Vitamin B-12(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Alpha Carotene(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Beta Carotene(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Retinol(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Beta Cryptoxanthin(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Lycopene(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E)(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: EPA (P205)(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: DHA (P226)(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: DPA (P225)(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Nuts and Seeds(Baseline (Burst 1) and 9 months (Burst 2))
- Symbol Search Task Performance(Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention)
- Grid Memory Task Performance(Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention)
- Color Shapes Task Performance(Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention)
- Self-reported Diet Components and Food Groups: Whole Grains(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Dark Green Vegetables(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Solid Fats(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Beans and Peas (Legumes)(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Cured Meats(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Poultry(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Cheeses(Baseline (Burst 1) and 9 months (Burst 2))
- Self-reported Diet Components and Food Groups: Added Sugars(Baseline (Burst 1) and 9 months (Burst 2))
研究者
Yasmin Mossavar-Rahmani
Professor of Epidemiology & Population Health
Albert Einstein College of Medicine