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Completed

NCT Number: NCT03419052

MINDSpeed Food and Brain Training RCT

The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regenstrief Institute

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial

Acronym: MINDSpeed

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2018
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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