Cognition, Cognitive Training, Low Education, Polyphenols
Conditions
Keywords
randomized controlled trial, cognition, cognitive training, MIND diet, quality of life, Alzheimer's disease
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.
Interventions
BEHAVIORALSpeed 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.
BEHAVIORALMIND 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.
BEHAVIORALCognitive 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.
BEHAVIORALControl foods
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Executive Cognitive Function Composite Score | 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. |
Countries
United States
Participant flow
Pre-assignment details
Enrolled participants were excluded from the study before group assignment when Baseline assessment or Tablet Orientation could not be completed.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 46 |
| 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. | 45 |
| 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. | 46 |
| Total | 180 |
Baseline characteristics
| Characteristic | MINDSpeed Intervention | Total | Double Control | Control Foods and Speed of Processing Training | MIND Food and Training Control |
|---|---|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 6.3 | 65.51 years STANDARD_DEVIATION 5.66 | 65.6 years STANDARD_DEVIATION 5.1 | 66.1 years STANDARD_DEVIATION 6.4 | 65.0 years STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 119 Participants | 25 Participants | 30 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 53 Participants | 18 Participants | 12 Participants | 12 Participants |
| Region of Enrollment United States | 43 Participants | 180 Participants | 46 Participants | 45 Participants | 46 Participants |
| Sex: Female, Male Female | 31 Participants | 117 Participants | 30 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 63 Participants | 16 Participants | 17 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 46 | 0 / 45 | 1 / 46 |
| other Total, other adverse events | 3 / 43 | 0 / 46 | 0 / 45 | 3 / 46 |
| serious Total, serious adverse events | 9 / 43 | 18 / 46 | 16 / 45 | 21 / 46 |
Outcome results
Primary
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.
Time frame: Immediately following the 12-week intervention (Immediate Post-Training)]
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MINDSpeed Intervention | Executive Cognitive Function Composite Score | 0.211 units on a scale |
| MIND Food and Training Control | Executive Cognitive Function Composite Score | 0.100 units on a scale |
| Control Foods and Speed of Processing Training | Executive Cognitive Function Composite Score | 0.142 units on a scale |
| Double Control | Executive Cognitive Function Composite Score | 0.196 units on a scale |