Clinical trial NCT04337255: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients
Official title: MIND Diet and Dementia Prevention in Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Dementia, Vascular
Alzheimer Disease
Dementia
Stroke
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Advocate Hospital System
name: National Institute on Aging (NIA)
First posted: 2020-04-07
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: MIND diet intervention
Primary purpose: PREVENTION

Brief summary: 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 250 patients hospitalized for acute ischemic stroke, aged 55 years or older, and without dementia who are discharged home following hospitalization.

Detailed description: 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 250 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 all trial participants. Other biochemical markers will be assessed in the entire group of 250 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Change in global cognitive score
timeFrame: 3-years
Secondary outcomes:
measure: 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)
timeFrame: 3-years
measure: Change in 5 individual cognitive domains
timeFrame: 3-years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Neelum T Aggarwal, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Christy Tangney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
citation: Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11.
citation: Cherian L, Wang Y, Fakuda K, Leurgans S, Aggarwal N, Morris M. Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) Diet Slows Cognitive Decline After Stroke. J Prev Alzheimers Dis. 2019;6(4):267-273. doi: 10.14283/jpad.2019.28.