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

NCT04337255 | Active Not Recruiting DMC

• 1 other identifier: 18052104-IRB01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  3-years

• Change in 5 individual cognitive domains

  3-years

Study Arms (2)

MIND DIET intervention

ACTIVE COMPARATOR

Allocation and blinding 3 year intervention of MIND Diet + counseling

Other: Behavioral Dietary intervention ( MIND Diet)

Usual care diet intervention

PLACEBO COMPARATOR

3 year Intervention of usual care diet + counseling

Other: Behavioral Usual Care Diet Intervention

Interventions

Behavioral Dietary intervention ( MIND Diet) OTHER

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.

MIND DIET intervention

Behavioral Usual Care Diet Intervention OTHER

The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components

Usual care diet intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Chicago: collaborator
• Advocate Hospital System: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 26086182 RESULT

• 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.

  PMID: 25681666 RESULT

• 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.

  PMID: 31686099 RESULT

• Ventrelle J, Lukaszewicz B, Claysen M, Setia B, Aggarwal NT, Tangney CC; NOURISH Study Team. A framework for monitoring intervention fidelity: The NOURISH trial. Contemp Clin Trials. 2025 Nov;158:108104. doi: 10.1016/j.cct.2025.108104. Epub 2025 Oct 4.

  PMID: 41052713 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia, Vascular; Alzheimer Disease; Dementia; Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Neelum T Aggarwal, MD.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Christy Tangney, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single ( Outcomes assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: MIND diet intervention

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: April 7, 2020
• Study Start: December 14, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months following publication of results
• Access Criteria: Review \& Approval by the Publications and Presentation Committee

Locations

US (1)