MINDSpeed Food and Brain Training RCT (MINDSpeed)

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

Study Overview

• Status: Completed
• Conditions: Low Education; Cognition; Cognitive Training; Polyphenols
• Intervention / Treatment: Behavioral: Speed of processing training; Behavioral: MIND foods; Behavioral: Cognitive training control; Behavioral: Control foods

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 Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Clark, PHD; Phone Number: 317 274 9292; Email: daniclar@iu.edu
• Study Contact Backup: Name: Lyndsi Moser, BA, CCRP; Phone Number: 317-963-7301; Email: lrhabegg@iupui.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Regenstrief Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MINDSpeed Intervention; Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training	Behavioral: 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.; 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.
Active Comparator: MIND food and training control; Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games	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.; 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.
Active Comparator: Control foods and speed of processing training; Consumption of low polyphenol foods AND speed of processing training	Behavioral: 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.; Behavioral: Control foods; Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Sham Comparator: Double Control; Consumption of low polyphenol foods AND online (inert) games	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.; Behavioral: Control foods; Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)]

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; Alzheimer's disease; quality of life; cognition; cognitive training; MIND diet
• Other Study ID Numbers: 1703766063; R01AG052439 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes