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MINDSpeed Food and Brain Training RCT (MINDSpeed)

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ClinicalTrials.gov Identifier: NCT03419052
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Daniel Clark, Indiana University

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

Condition or disease Intervention/treatment Phase
Low Education Behavioral: Speed of processing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MINDSpeed Food and Brain Training RCT
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

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

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration.

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) tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.(93) The Posit program systematically reduces stimulus presentation time to maintain an 85% accuracy rate and launches each new session based on the stopping point of the preceding session. Participants receive performance ratings relative to their prior trial upon completion of each "exercise." Participants will be incentivized to train 15 minutes (minimum), 5 days per week for 12 weeks.


Experimental: MIND food and training control
Consumption of foods high in polyphenols and online (inert) games
Behavioral: Speed of processing

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration.

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) tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.(93) The Posit program systematically reduces stimulus presentation time to maintain an 85% accuracy rate and launches each new session based on the stopping point of the preceding session. Participants receive performance ratings relative to their prior trial upon completion of each "exercise." Participants will be incentivized to train 15 minutes (minimum), 5 days per week for 12 weeks.


Experimental: Control foods and speed of processing traini
Consumption of low polyphenol foods and speed of processing training
Behavioral: Speed of processing

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration.

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) tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.(93) The Posit program systematically reduces stimulus presentation time to maintain an 85% accuracy rate and launches each new session based on the stopping point of the preceding session. Participants receive performance ratings relative to their prior trial upon completion of each "exercise." Participants will be incentivized to train 15 minutes (minimum), 5 days per week for 12 weeks.


Active Comparator: Control
Consumption of low polyphenol foods and online (inert) games
Behavioral: Speed of processing

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration.

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) tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.(93) The Posit program systematically reduces stimulus presentation time to maintain an 85% accuracy rate and launches each new session based on the stopping point of the preceding session. Participants receive performance ratings relative to their prior trial upon completion of each "exercise." Participants will be incentivized to train 15 minutes (minimum), 5 days per week for 12 weeks.





Primary Outcome Measures :
  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 worth function and higher scores represent better function.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • age 60 years or older,
  • ≤ 12 years of education,
  • English speaking,
  • Marion County resident,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419052


Contacts
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Contact: Daniel Clark, PHD 317 274 9292 daniclar@iu.edu
Contact: Denisha Y Ferguson, MBA 317 274 9082 deniferg@iupui.edu

Locations
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United States, Indiana
Regenstrief Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Denisha Ferguson, MBA    317-274-9082    deniferg@iupui.edu   
Principal Investigator: Daniel Clark, PHD         
Sponsors and Collaborators
Indiana University
National Institutes of Health (NIH)

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Responsible Party: Daniel Clark, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03419052     History of Changes
Other Study ID Numbers: 1703766063
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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
Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors