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

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ClinicalTrials.gov Identifier: NCT04337255
Recruitment Status : Not yet recruiting
First Posted : April 7, 2020
Last Update Posted : November 30, 2020
Sponsor:
Collaborators:
University of Chicago
Advocate Hospital System
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neelum T. Aggarwal, MD, Rush University Medical Center

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 60-80 years and without dementia who are discharged home following hospitalization.

Condition or disease Intervention/treatment Phase
Cognitive Decline Dementia, Vascular Alzheimer Disease Dementia Stroke Other: Behavioral Dietary intervention ( MIND Diet) Other: Behavioral Usual Care Diet Intervention Not Applicable

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 clinical sites, Rush University Medical Center, University of Chicago, and Advocate Christ Hospital all located in Chicago.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MIND diet intervention
Masking: Single (Outcomes Assessor)
Masking Description: Single ( Outcomes assessor)
Primary Purpose: Prevention
Official Title: MIND Diet and Dementia Prevention in Ischemic Stroke Patients
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    300 participants total ( 150 in each treatment group)

  2. 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.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria
  • Men and women, 60-80 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
  • MoCA<22 or COR>=O.S
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337255


Contacts
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Contact: Neelum T Aggarwal, MD 312 942 2338 neelum_t_aggarwal@rush.edu
Contact: Christy C Tangney, Ph.D. 3129425995 ctangney@rush.edu

Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
University of Chicago
Advocate Hospital System
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Neelum T Aggarwal, MD. Rush University Medical Center
Principal Investigator: Christy Tangney, PhD Rush University Medical Center
Publications of Results:
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Responsible Party: Neelum T. Aggarwal, MD, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04337255    
Other Study ID Numbers: 18052104-IRB01
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Electronic data will be made available after trial completion
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months following publication of results
Access Criteria: Review & Approval by the Publications and Presentation Committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Alzheimer Disease
Dementia
Dementia, Vascular
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases