MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Executive Cognitive Function Composite Score
Study Overview
Brief Summary
The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance
Detailed Description
Adults with low education who give informed consent will complete a baseline cognitive assessment and then be randomized to one of four arms: 1) MIND foods and cognitive training, 2) MIND foods and control training, 3) control foods and cognitive training, or 4) control foods and control training.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
MINDSpeed Intervention
Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training
Intervention: MIND foods (Behavioral)
MINDSpeed Intervention
Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training
Intervention: Speed of processing training (Behavioral)
MIND food and training control
Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games
Intervention: MIND foods (Behavioral)
MIND food and training control
Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games
Intervention: Cognitive training control (Behavioral)
Control foods and speed of processing training
Consumption of low polyphenol foods AND speed of processing training
Intervention: Speed of processing training (Behavioral)
Control foods and speed of processing training
Consumption of low polyphenol foods AND speed of processing training
Intervention: Control foods (Behavioral)
Double Control
Consumption of low polyphenol foods AND online (inert) games
Intervention: Cognitive training control (Behavioral)
Double Control
Consumption of low polyphenol foods AND online (inert) games
Intervention: Control foods (Behavioral)
Outcomes
Primary Outcomes
Executive Cognitive Function Composite Score
Time Frame: Immediately following the 12-week intervention (Immediate Post-Training)]
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Clark
Associate Professor of Medicine
Indiana University