Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients

Study Overview
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Brief Summary
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To test the effects of a 2- to 3-year intervention of the MIND diet versus usual post-stroke care on cognitive decline, the characteristic feature of dementia, and on brain biomarkers of Alzheimer's Disease (AD) and vascular disease in a Phase Ill randomized controlled trial of 500 patients hospitalized for acute ischemic stroke, aged 55 years or older, and without dementia who are discharged home following hospitalization.

Detailed Description
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The Mediterranean-DASH diet intervention for Neurodegenerative Delay (MIND in Stroke patients is designed to test the effects of a 2-3 year intervention of a hybrid of the Mediterranean and DASH diets, called MIND on 500 older patients, without dementia who are hospitalized for acute stroke who are discharged home following hospitalization. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetable and berries as well as food component servings that reflect the nutrition dementia evidence. In this study we will test the effects of a 2- to 3-year intervention of the MIND diet (3 months of delivered meals followed by dietary and general stroke health counseling) versus usual post-stroke care (3 months delivered self-selected meals followed by general stroke health counseling) on change on cognitive outcomes over 24 to 36 months. Biological effects of the MIND diet will be assessed by measurement of brain macro and microstructural integrity in 300 trial participants randomly selected participants. Other biochemical markers will be assessed in the entire group of 500 participants including: plasma Abeta42/beta40, brain derived neurotropic factor (BDNF) and plasma markers of oxidative stress and inflammation. The trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers and biological mechanisms. The proposed study has 3 recruitment sites, Rush University Medical Center, University of Chicago, and Advocate Christ Hospital all located in Chicago.

Official Title
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MIND Diet and Dementia Prevention in Ischemic Stroke Patients

Conditions
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Cognitive Decline, Dementia, Vascular, Alzheimer Disease, Dementia, Stroke

Intervention / Treatment
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* Other: Behavioral Dietary intervention ( MIND Diet)
* Other: Behavioral Usual Care Diet Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Men and women, 55 years of age - inclusive- or older Acute stroke as defined by an acute focal neurological deficit in combination with one of the following: acute ischemic infarct (stroke) as documented by either a DWl positive lesion on MR imaging or a new lesion on a delayed CT scan Written informed consent by patient prior to study participation Willingness to complete all assessments and participate in follow-up Willing to participate and give informed consent Adequate Visual and auditory acuity to undergo neuropsychological testing Exclusion criteria CDR>=0.5 Nuts, berries, olive oil, or fish allergies Use of medications to treat Alzheimer's disease or Parkinson's disease Aphasia Conditions of psychosis or bipolar disorder judged by study investigators to potentially interfere with study compliance over 3 years Report of alcohol or substance abuse within six months, or heavy alcohol consumption (>2 drinks/d women; >3 drinks/d men) Unstable or recent onset of cardiovascular disease, such as myocardial infarction within six months or presence of congestive heart failure (Stages II-IV) Cancer treatment <= 5 years except non-melanoma skin cancer , basal cell skin cancer (this criterion may be waived at the site PI's discretion) Illness that might be associated with weight change, such as a history of stomach or gastrointestinal conditions (Inflammatory Bowel Disease, Crohn's Disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, etc.) History of liver disease, HIV or Hepatitis C An intracerebral hemorrhage as documented on CT or MRI Pre- hospitalization diagnosis of dementia or mild cognitive impairment Patients presenting one of the following diseases: cerebral venous thrombosis, traumatic cerebral hemorrhage, intracerebral hemorrhage because of a known or image-guided assumed vascular malformation, pure meningeal or intraventricular hemorrhage Patients presenting a malignant disease with life expectancy < 3 years Residence in a nursing home and thus going back to nursing home upon discharge Participation in an ongoing investigational drug study Exception to these guidelines will be rare but may be considered on a case by case basis at the discretion of the PI's

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: MIND diet intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MIND DIET intervention<br>Allocation and blinding 3 year intervention of MIND Diet + counseling | Other: Behavioral Dietary intervention ( MIND Diet)<br>* The MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition dementia evidence.<br>|
| Placebo Comparator: Usual care diet intervention<br>3 year Intervention of usual care diet + counseling | Other: Behavioral Usual Care Diet Intervention<br>* The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global cognitive score | 3-year change in global cognitive score. The global cognitive score is a composite score, based on the average of z scores of the 19 individual tests scores, with a mean of 0 and standard deviation of 1. Higher scores reflect high global cognitive function. | 3-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain MRI derived markers of macro and micro structural integrity (cubic Centimeters), total brain volume, hippocampal volume and white matter hyperintensity volume ( cubic centimeters) | 300 participants total ( 150 in each treatment group) | 3-years | 
| Change in 5 individual cognitive domains | Change in 5 individual domains that include executive functioning, perceptual speed, episodic memory, semantic and working memory. Each domain is made up of atleast 2 cognitive tests that are z scored and averaged for that domain. Higher scores on each domain reflects higher cognition in that domain. | 3-years |