MINDSpeed Food and Brain Training RCT

NCT ID: NCT03419052

Last Updated: 2025-03-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2024-03-08

Brief Summary

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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

Detailed Description

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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

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Low Education Cognition Cognitive Training Polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MINDSpeed Intervention

Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training

Group Type EXPERIMENTAL

Speed of processing training

Intervention Type 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.

MIND foods

Intervention Type 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.

MIND food and training control

Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games

Group Type ACTIVE_COMPARATOR

MIND foods

Intervention Type 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

Intervention Type 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 and speed of processing training

Consumption of low polyphenol foods AND speed of processing training

Group Type ACTIVE_COMPARATOR

Speed of processing training

Intervention Type 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.

Control foods

Intervention Type BEHAVIORAL

Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.

Double Control

Consumption of low polyphenol foods AND online (inert) games

Group Type SHAM_COMPARATOR

Cognitive training control

Intervention Type 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

Intervention Type BEHAVIORAL

Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Control foods

Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Daniel Clark

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Regenstrief Institute

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40442881 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AG052439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1703766063

Identifier Type: -

Identifier Source: org_study_id

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