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

April 16, 2026 updated by: Neelum T. Aggarwal, MD, Rush University Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MIND DIET intervention
Allocation and blinding 3 year intervention of MIND Diet + counseling
Other: Behavioral Dietary intervention ( MIND Diet)
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.
Placebo Comparator: Usual care diet intervention
3 year Intervention of usual care diet + counseling
Other: Behavioral Usual Care Diet Intervention
The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global cognitive score
Time Frame: 3-years
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 5 individual cognitive domains
Time Frame: 3-years
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
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)
Time Frame: 3-years
130 participants total ( 65 in each treatment group)
3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

University of Chicago
National Institute on Aging (NIA)
Advocate Hospital System

Investigators

  • Principal Investigator: Neelum T Aggarwal, MD., Rush University Medical Center
  • Principal Investigator: Christy Tangney, PhD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

April 4, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18052104-IRB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Electronic data will be made available after trial completion

IPD Sharing Time Frame

6 months following publication of results

IPD Sharing Access Criteria

Review & Approval by the Publications and Presentation Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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