Dieta Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) en pacientes con accidente cerebrovascular
Dieta MIND y prevención de la demencia en pacientes con accidente cerebrovascular isquémico
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: MIND DIET intervention
Allocation and blinding 3 year intervention of MIND Diet + counseling |
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. |
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Comparador de placebos: Usual care diet intervention
3 year Intervention of usual care diet + counseling |
The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in global cognitive score
Periodo de tiempo: 3-years
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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)
Periodo de tiempo: 3-years
|
130 participants total ( 65 in each treatment group) |
3-years
|
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Change in 5 individual cognitive domains
Periodo de tiempo: 3-years
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Neelum T Aggarwal, MD., Rush University Medical Center
- Investigador principal: Christy Tangney, PhD, Rush University Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
- Barnes LL, Dhana K, Liu X, Carey VJ, Ventrelle J, Johnson K, Hollings CS, Bishop L, Laranjo N, Stubbs BJ, Reilly X, Agarwal P, Zhang S, Grodstein F, Tangney CC, Holland TM, Aggarwal NT, Arfanakis K, Morris MC, Sacks FM. Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. N Engl J Med. 2023 Aug 17;389(7):602-611. doi: 10.1056/NEJMoa2302368. Epub 2023 Jul 18.
- Halloway S, Dhana K, Desai P, Agarwal P, Holland T, Aggarwal NT, Evers J, Sacks FM, Carey VJ, Barnes LL. Free-Living Standing Activity as Assessed by Seismic Accelerometers and Cognitive Function in Community-Dwelling Older Adults: The MIND Trial. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1981-1987. doi: 10.1093/gerona/glab106.
- Dhana K, Aggarwal NT, Voigt RM, Ventrelle J, Rajan KB, Kaddurah-Daouk R, Marcovina SM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Effect of weight loss through dietary interventions on cardiometabolic health in older adults. Int J Obes (Lond). 2025 Dec;49(12):2503-2510. doi: 10.1038/s41366-025-01902-6. Epub 2025 Oct 3.
- Liu X, Dhana K, Furtado JD, Agarwal P, Aggarwal NT, Tangney C, Laranjo N, Carey V, Barnes LL, Sacks FM. Higher circulating alpha-carotene was associated with better cognitive function: an evaluation among the MIND trial participants. J Nutr Sci. 2021 Aug 16;10:e64. doi: 10.1017/jns.2021.56. eCollection 2021.
- Dhana K, Aggarwal NT, Ventrelle J, Voigt RM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and longitudinal changes in global cognition: a post hoc analysis of the MIND trial. Am J Clin Nutr. 2026 Jul 15;124(3):101433. doi: 10.1016/j.ajcnut.2026.101433. Online ahead of print.
- Dhana K, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Dietary intervention and cognition across Alzheimer's disease biomarker levels: The MIND clinical trial. J Alzheimers Dis. 2026 Jun;111(3):1301-1308. doi: 10.1177/13872877261442856. Epub 2026 Apr 25.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Trastornos neurocognitivos
- Trastornos cognitivos
- Tauopatías
- Enfermedades neurodegenerativas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Leucoencefalopatías
- Arteriosclerosis intracraneal
- Enfermedades Arteriales Intracraneales
- Carrera
- Disfunción congnitiva
- Enfermedad de Alzheimer
- Demencia
- Demencia Vascular
Otros números de identificación del estudio
- 18052104-IRB01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Electronic data will be made available after trial completion
Marco de tiempo para compartir IPD
6 months following publication of results
Criterios de acceso compartido de IPD
Review & Approval by the Publications and Presentation Committee
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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