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

Primary Purpose

Cognitive Decline, Dementia, Vascular, Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Dietary intervention ( MIND Diet)

Behavioral Usual Care Diet Intervention

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria
Men and women, 55-80 years of age - inclusive
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

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MIND DIET intervention

Usual care diet intervention

Arm Description

Allocation and blinding 3 year intervention of MIND Diet + counseling

3 year Intervention of usual care diet + counseling

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

300 participants total ( 150 in each treatment group)

Change in 5 individual cognitive domains

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.

Full Information

NCT ID

NCT04337255

First Posted

December 12, 2019

Last Updated

June 26, 2023

Sponsor

Rush University Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04337255

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 500 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 500 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 300 trial participants randomly selected participants. Other biochemical markers will be assessed in the entire group of 500 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

MIND diet intervention

Masking

Outcomes Assessor

Masking Description

Single ( Outcomes assessor)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MIND DIET intervention

Arm Type

Active Comparator

Arm Description

Allocation and blinding 3 year intervention of MIND Diet + counseling

Arm Title

Usual care diet intervention

Arm Type

Placebo Comparator

Arm Description

3 year Intervention of usual care diet + counseling

Intervention Type

Other

Intervention Name(s)

Behavioral Dietary intervention ( MIND Diet)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Behavioral Usual Care Diet Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in global cognitive score

Description

Time Frame

3-years

Secondary Outcome Measure Information:

Title

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)

Description

300 participants total ( 150 in each treatment group)

Time Frame

3-years

Title

Change in 5 individual cognitive domains

Description

Time Frame

3-years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Neelum T Aggarwal, MD

Phone

312 942 2338

neelum_t_aggarwal@rush.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Christy C Tangney, Ph.D.

Phone

3129425995

ctangney@rush.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neelum T Aggarwal, MD.

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christy Tangney, PhD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

26086182

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.

Results Reference

result

PubMed Identifier

25681666

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.

Results Reference

result

PubMed Identifier

31686099

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.

Results Reference

result

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

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