CLINICAL TRIAL / NCT04337255
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients
- Interventional
- Active
- NCT04337255
Contact Information
MIND Diet and Dementia Prevention in Ischemic Stroke Patients
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.
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.
Gender
All
Age Group
55 Years and up
Accepting Healthy Volunteers
No
- 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