AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults

Study Overview
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Brief Summary
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The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires.

Official Title
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AvoCog - The Effect of Daily Avocado Intake on Cognitive Function in Older Adults

Conditions
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Brain Aging

Intervention / Treatment
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* Other: Avocado Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 65-85 years Good general health with no concomitant disease BMI 18.5 - 35 kg/m2 Mini Mental State Exam ≥26 Reports consuming ≤2 medium avocados per month Reports consuming ≤3 servings of carotenoid-rich foods per week and ≤3 servings of fruits and vegetables per day Skin carotenoid content <400 Exclusion Criteria: Unwilling or unable to consume avocado Latex allergy Consistently taking lutein + zeaxanthin supplements Skin carotenoid content ≥400 Central neurological disease such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, brain tumor, etc. Serious medical risk: cancer requiring chemotherapy or radiation within the past 5 years, recent cardiac event (i.e. heart attack, etc.) Diabetes mellitus or uncontrolled hypertension Use of psychoactive or investigational medications Consumption of ≥3 alcoholic drinks per day or substance abuse Unable to undergo MRI

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants will be randomly assigned equally to either the intervention or the control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avocado Group<br>Participants will consume 1 avocado per day and receive education to maintain usual caloric intake for 12 weeks and participate in 4 study visits. | Other: Avocado Group<br>* Participants will consume provided avocados daily and track consumption for the duration of the study. Participants will be adding avocados to their diet and will receive education on maintaining usual diet.<br>|
| No Intervention: No Diet Modification Group<br>Participants will continue their normal dietary pattern for 12 weeks and participate in 4 study visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain activity | MRI will be used to measure changes in brain activity during resting state, a working memory task, and executive function task. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cerebral blood flow | MRI will be used to measure change in cerebral blood flow. | Baseline and 12 weeks | 
| Changes in memory and executive function | NIH Toolbox will be used to measure change in cognition throughout the study. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avocado, Older Adults, Brain Health, Brain Imaging, Cognition, Dietary Intervention