MINDSpeed Food and Brain Training RCT

Cognition Clinical Trial

— MINDSpeed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419052
• Other study ID #: 1703766063
• Secondary ID: R01AG052439
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: March 8, 2024

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Cognitive Training
• Low Education
• Polyphenols

Intervention

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

Locations

Country	Name	City	State
United States	Regenstrief Institute	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately following the 12-week intervention (Immediate Post-Training)]