Multicultural Healthy Diet to Reduce Cognitive Decline

Study Overview
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Brief Summary
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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.

Detailed Description
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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 markers of oxidative stress and 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.

Official Title
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Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk

Conditions
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Diet Modification, Cognitive Decline, Cognitive Change

Intervention / Treatment
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* Other: Multicultural Healthy Diet
* Other: Usual Diet plus Self-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot randomized clinical trial to the effects of an anti-inflammatory diet on cognition in a middle-aged cohort. The comparison arm will receive information on self-care matters such as aches and pains of aging.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anti-inflammatory dietary intervention<br>18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, | Other: Multicultural Healthy Diet<br>* An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential<br>|
| Placebo Comparator: Usual Diet plus Self-Care<br>18 month intervention of usual diet plus self-care modules | Other: Usual Diet plus Self-Care<br>* Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite cognition score | 9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing visuospatial working memory, processing speed and short-term associative memory binding. Composite score is based on the average of z-scores of the individual test scores. | 9 months post baseline |