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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Aging
• Intervention / Treatment: Other: Avocado Group

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Taylor, PHD; Phone Number: 913-588-5363; Email: mtaylor3@kumc.edu
• Study Contact Backup: Name: Emma Kelly, MS; Phone Number: 913-588-7683; Email: ekelly9@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Emma Kelly, MS; Phone Number: 913-588-7683; Email: ekelly9@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avocado Group; 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; 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.
No Intervention: No Diet Modification Group; Participants will continue their normal dietary pattern for 12 weeks and participate in 4 study visits.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Avocado Nutrition Center

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Older Adults; Cognition; Brain Imaging; Dietary Intervention; Brain Health; Avocado
• Other Study ID Numbers: 00150975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No