MINDSpeed Food and Brain Training RCT
MINDSpeed
MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial
2 other identifiers
interventional
212
1 country
1
Brief Summary
The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2024
CompletedResults Posted
Study results publicly available
March 7, 2025
CompletedMarch 7, 2025
February 1, 2025
5.2 years
January 26, 2018
February 17, 2025
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive Cognitive Function Composite Score
Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Verbal Fluency, Complex Sequencing, Response Inhibition, and List Learning. The scale score range is -20 to 20. Low scores represent worse function and higher scores represent better function.
Immediately following the 12-week intervention (Immediate Post-Training)]
Study Arms (4)
MINDSpeed Intervention
EXPERIMENTALConsumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training
MIND food and training control
ACTIVE COMPARATORConsumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games
Control foods and speed of processing training
ACTIVE COMPARATORConsumption of low polyphenol foods AND speed of processing training
Double Control
SHAM COMPARATORConsumption of low polyphenol foods AND online (inert) games
Interventions
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.
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.
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.
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Eligibility Criteria
You may qualify if:
- age 60 years or older,
- ≤ 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.
You may not qualify if:
- living in nursing home
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Regenstrief Institute
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 40442881DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Clark, PhD
- Organization
- Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 26, 2018
First Posted
February 1, 2018
Study Start
January 10, 2019
Primary Completion
March 8, 2024
Study Completion
March 8, 2024
Last Updated
March 7, 2025
Results First Posted
March 7, 2025
Record last verified: 2025-02