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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG052439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINDSpeed Intervention | Experimental | Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training |
|
| MIND food and training control | Active Comparator | Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games |
|
| Control foods and speed of processing training | Active Comparator | Consumption of low polyphenol foods AND speed of processing training |
|
| Double Control | Sham Comparator | Consumption of low polyphenol foods AND online (inert) games |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speed of processing training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenstrief Institute | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40442881 | Derived | 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. |
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Enrolled participants were excluded from the study before group assignment when Baseline assessment or Tablet Orientation could not be completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Immediate Post-Training |
| |||||||||||||
| Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately following the 12-week intervention (Immediate Post-Training)] |
|
Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first.
Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Clark, PhD | Indiana University | 317-274-9292 | daniclar@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Feb 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2023 | Nov 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| MIND foods | Behavioral | 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 | Behavioral | 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 | Behavioral | Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 0 |
| 43 |
| 9 |
| 43 |
| 3 |
| 43 |
| EG001 | 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. | 0 | 46 | 18 | 46 | 0 | 46 |
| EG002 | 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. | 0 | 45 | 16 | 45 | 0 | 45 |
| EG003 | 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. | 1 | 46 | 21 | 46 | 3 | 46 |
| Asthma and bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COVID | Infections and infestations | Systematic Assessment |
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| Flu | Infections and infestations | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
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| Mild heart attack | Cardiac disorders | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Angina | Cardiac disorders | Systematic Assessment |
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| Assault | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dehydration | General disorders | Systematic Assessment |
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| Frailty | General disorders | Systematic Assessment |
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| Function loss from femur break | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Hernia | Surgical and medical procedures | Systematic Assessment |
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| Orthopedic surgery | Surgical and medical procedures | Systematic Assessment |
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| Reactive airway disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Toe ulcer | Infections and infestations | Systematic Assessment |
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| Venous stasis ulcer | Vascular disorders | Systematic Assessment |
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| Viral illness | Infections and infestations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| CHF complication | Cardiac disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Kidney mass | Surgical and medical procedures | Systematic Assessment |
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| Knee surgery | Surgical and medical procedures | Systematic Assessment |
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| Myocardial infarction rule out | Cardiac disorders | Systematic Assessment |
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| Urinary track infection | Renal and urinary disorders | Systematic Assessment |
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| Breast cancer | Surgical and medical procedures | Systematic Assessment |
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| Bunion | Surgical and medical procedures | Systematic Assessment |
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| Carpal tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cysts | Reproductive system and breast disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Diverticulosis | Gastrointestinal disorders | Systematic Assessment |
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| Lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Mobility issues | General disorders | Systematic Assessment |
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| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nursing home placement | General disorders | Systematic Assessment |
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| Oral pain | General disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Vaccine reaction | Product Issues | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |