Clinical trial NCT02817074: MIND Diet Intervention and Cognitive Decline
Official title: MIND Diet Intervention to Prevent Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Dementia
Alzheimer Disease
Vascular Dementia
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Brigham and Women's Hospital
name: National Institute on Aging (NIA)
First posted: 2016-06-29
Enrollment: 604
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.

Detailed description: Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed 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. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, 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 two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham \& Women's Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.

Eligibility criteria: Inclusion Criteria:

* family history of dementia
* BMI \>=25
* suboptimal diet

Exclusion Criteria:

* heavy alcohol use
* severe illness
* cognitively impaired
* psychiatric illness

Primary outcomes:
measure: Change in global cognitive function (composite score)
timeFrame: 3 years
measure: Change in specific cognitive domains
timeFrame: 3 years
Secondary outcomes:
measure: Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)
timeFrame: 3 years
Other outcomes:
measure: Exploratory aim 1: Incidence of cardiovascular disease
timeFrame: 3 years
measure: Exploratory aim 2a: Blood pressure
timeFrame: 3 years
measure: Exploratory aim 2b: Total cholesterol
timeFrame: 3 years
measure: Exploratory aim 2c: Low-density lipoprotein (LDL)
timeFrame: 3 years
measure: Exploratory aim 2d: High-density lipoprotein (HDL)
timeFrame: 3 years
measure: Exploratory aim 2e: Hemoglobin A1c (HbA1c)
timeFrame: 3 years
measure: Exploratory aim 3: Plasma amyloid beta (Abeta)
timeFrame: 3 years
measure: Exploratory aim 4a: C-Reactive Protein (CRP)
timeFrame: 3 years
measure: Exploratory aim 4b: Interleukin 6 (IL-6)
timeFrame: 3 years
measure: Exploratory aim 4c: Oxidized LDL
timeFrame: 3 years
measure: Exploratory aim 4d: Estimated glomerular filtration rate (eGFR)
timeFrame: 3 years
measure: Exploratory aim 4e: Brain-derived neurotrophic factor
timeFrame: 3 years
measure: Exploratory aim 4f: Adiponectin
timeFrame: 3 years
Locations:
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Rush University
name: Lisa L Barnes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Lefevre-Arbogast S, Dhana K, Aggarwal NT, Zhang S, Agarwal P, Liu X, Laranjo N, Carey V, Sacks F, Barnes LL, Arfanakis K. Vitamin D Intake and Brain Cortical Thickness in Community-Dwelling Overweight Older Adults: A Cross-Sectional Study. J Nutr. 2021 Sep 4;151(9):2760-2767. doi: 10.1093/jn/nxab168.
citation: 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.
citation: 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.