Study Results
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View full resultsBasic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2019-01-10
2024-03-08
Brief Summary
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Detailed Description
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All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration. Cognitive training is delivered through the online BrainHQ program from Posit Science, Inc. The foods will be shown on the tablet device in an online shopping format. Selected foods will be prepared and delivered by the study team.
Active intervention will last for 12 weeks. After the 12-weeks, free food deliveries will cease but participants who were allocated to cognitive training will continue to have access to BrainHQ. Those in the MIND food arms will be encouraged to maintain MIND food consumption.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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MINDSpeed Intervention
Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training
Speed of processing training
Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.
MIND foods
The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.
MIND food and training control
Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games
MIND foods
The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.
Cognitive training control
Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.
Control foods and speed of processing training
Consumption of low polyphenol foods AND speed of processing training
Speed of processing training
Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.
Control foods
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Double Control
Consumption of low polyphenol foods AND online (inert) games
Cognitive training control
Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.
Control foods
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Interventions
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Speed of processing training
Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.
MIND foods
The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.
Cognitive training control
Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.
Control foods
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Eligibility Criteria
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Inclusion Criteria
* ≤ 12 years of education,
* English speaking,
* Marion County (and immediately surrounding counties) resident, with steady/fixed residence to receive food deliveries
* natural-born US citizen.
Exclusion Criteria
* self-reported diagnosis of dementia, Alzheimer's disease (AD), cancer with short life expectancy, multiple sclerosis, epilepsy, schizophrenia, bipolar disorder, Parkinson disease; current chemotherapy or radiation therapy; history of brain tumor, brain surgery, brain infection; stroke or myocardial infarction within the past 12 months
* current alcohol consumption ≥8 drinks per week for women or ≥15 drinks per week for men;
* poor vision (self-reported difficulty reading a newspaper) or color blind;
* low communicative ability (examiner rated) that would interfere with interventions and assessments;
* prior involvement in similar cognitive training studies;
* unable or unwilling to provide blood sample at Baseline
* tumor, hemorrhage, aneurysm, hydrocephalus, or other significant clinical finding from Baseline brain MRI
60 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
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Daniel Clark
Associate Professor of Medicine
Locations
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Regenstrief Institute
Indianapolis, Indiana, United States
Countries
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References
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Clark DO, Xu H, Tangney CC, Lin AW, Risacher SL, Saykin AJ, Considine RV, Garringer HJ, Moser L, Carter A, Miller CM, Sprague B, Callahan CM, Unverzagt FW. Feasibility of lifestyle interventions for cognition in adults with low education. Alzheimers Dement. 2025 May;21(5):e70232. doi: 10.1002/alz.70232.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1703766063
Identifier Type: -
Identifier Source: org_study_id
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