Low EducationMINDSpeedNCT03419052
MINDSpeed Food and Brain Training RCT
A study testing Speed of processing training and MIND foods in people with Low Education and Cognition, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Education, Cognition, Cognitive Training
- What is being tested?
- Speed of processing training and MIND foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2019to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial
The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance
Read the 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.
- Conditions
- Low Education, Cognition, Cognitive Training, Polyphenols
- Being tested
- Speed of processing training, MIND foods, Cognitive training control, Control foods
- Keywords
- randomized controlled trial, cognition, cognitive training, MIND diet, quality of life, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed of processing trainingBehavioural
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 foodsBehavioural
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 controlBehavioural
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 foodsBehavioural
Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
| Study group | Role | What they receive |
|---|---|---|
| MINDSpeed Intervention | Experimental | Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Receives: Behavioral: Speed of processing training; Behavioral: MIND foods |
| MIND food and training control | Active comparator | Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games Receives: Behavioral: MIND foods; Behavioral: Cognitive training control |
| Control foods and speed of processing training | Active comparator | Consumption of low polyphenol foods AND speed of processing training Receives: Behavioral: Speed of processing training; Behavioral: Control foods |
| Double Control | Sham comparator | Consumption of low polyphenol foods AND online (inert) games Receives: Behavioral: Cognitive training control; Behavioral: Control foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following the 12-week intervention (Immediate Post-Training)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start10 Jan 2019
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Daniel Clark, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419052
- Sponsor's protocol ID
- 1703766063
- Other IDs
- R01AG052439
- Acronym
- MINDSpeed
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2018
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40442881
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial
- ClinicalTrials.gov ID
- NCT03419052
- Acronym / sponsor ID
- MINDSpeed / 1703766063
- Conditions
- Low Education, Cognition, Cognitive Training, Polyphenols
- Keywords
- randomized controlled trial, cognition, cognitive training, MIND diet, quality of life, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MINDSpeed Intervention | Experimental | Behavioral: Speed of processing training, Behavioral: MIND foodsConsumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training |
| MIND food and training control | Active comparator | Behavioral: MIND foods, Behavioral: Cognitive training controlConsumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games |
| Control foods and speed of processing training | Active comparator | Behavioral: Speed of processing training, Behavioral: Control foodsConsumption of low polyphenol foods AND speed of processing training |
| Double Control | Sham comparator | Behavioral: Cognitive training control, Behavioral: Control foodsConsumption of low polyphenol foods AND online (inert) games |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speed of processing trainingSpeed 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. | Behavioural | Control foods and speed of processing training, MINDSpeed Intervention |
| MIND foodsThe "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. | Behavioural | MIND food and training control, MINDSpeed Intervention |
| Cognitive training controlControl 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. | Behavioural | Double Control, MIND food and training control |
| Control foodsFoods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery. | Behavioural | Control foods and speed of processing training, Double Control |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40442881Clark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of processing training and MIND foods in people with Low Education and Cognition, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Cognitive Function Composite Score (time frame: Immediately following the 12-week intervention (Immediate Post-Training)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.