Välimeren DASH-interventio neurodegeneratiivisen viivästymisen (MIND) ruokavalioon aivohalvauspotilailla
MIND-ruokavalio ja dementian ehkäisy iskeemisillä aivohalvauspotilailla
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- Rush University Medical Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
- 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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: 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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Placebo Comparator: 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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in global cognitive score
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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)
Aikaikkuna: 3-years
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130 participants total ( 65 in each treatment group) |
3-years
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Change in 5 individual cognitive domains
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Neelum T Aggarwal, MD., Rush University Medical Center
- Päätutkija: Christy Tangney, PhD, Rush University Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Aivoverenkiertohäiriöt
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Mielenterveyshäiriöt
- Neurokognitiiviset häiriöt
- Kognitiohäiriöt
- Tauopatiat
- Neurodegeneratiiviset sairaudet
- Valtimotauti
- Valtimon tukossairaudet
- Leukoenkefalopatiat
- Intrakraniaalinen arterioskleroosi
- Kallonsisäiset valtimotaudit
- Aivohalvaus
- Kognitiivinen toimintahäiriö
- Alzheimerin tauti
- Dementia
- Dementia, vaskulaarinen
Muut tutkimustunnusnumerot
- 18052104-IRB01
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Electronic data will be made available after trial completion
IPD-jaon aikakehys
6 months following publication of results
IPD-jaon käyttöoikeuskriteerit
Review & Approval by the Publications and Presentation Committee
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
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