Clinical trial NCT03419052: MINDSpeed Food and Brain Training RCT
Official title: MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Education
Cognition
Cognitive Training
Polyphenols
Keywords: randomized controlled trial
cognition
cognitive training
MIND diet
quality of life
Alzheimer's disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2018-02-01
Enrollment: 212
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Executive Cognitive Function Composite Score
timeFrame: Immediately following the 12-week intervention (Immediate Post-Training)]
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute
state: Indiana
Study officials:
References: