Status:
ACTIVE_NOT_RECRUITING
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
University of Chicago
Advocate Hospital System
Conditions:
Cognitive Decline
Dementia, Vascular
Eligibility:
All Genders
55+ years
Phase:
NA
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 D...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04337255
Start Date
December 14 2021
End Date
May 31 2027
Last Update
March 10 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612