MINDSpeed Food and Brain Training RCT

Indiana University

Status: Completed

Conditions: Low Education; Cognitive Training; Cognition; Polyphenols

Treatments: Behavioral: Speed of processing training; Behavioral: Control foods; Behavioral: MIND foods; Behavioral: Cognitive training control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03419052

1703766063

R01AG052439 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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212 participants in 4 patient groups

MINDSpeed Intervention

Experimental group

Description:

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

Treatment:

Behavioral: MIND foods

Behavioral: Speed of processing training

MIND food and training control

Active Comparator group

Description:

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

Treatment:

Behavioral: MIND foods

Behavioral: Cognitive training control

Control foods and speed of processing training

Active Comparator group

Description:

Consumption of low polyphenol foods AND speed of processing training

Treatment:

Behavioral: Speed of processing training

Behavioral: Control foods

Double Control

Sham Comparator group

Description:

Consumption of low polyphenol foods AND online (inert) games

Treatment:

Behavioral: Control foods

Behavioral: Cognitive training control