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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137339

Collaborator

Avocado Nutrition Center (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Aging	Other: Avocado Group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study participants will be randomly assigned equally to either the intervention or the control group.Study participants will be randomly assigned equally to either the intervention or the control group.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Participants cannot be blinded to their allocation in order to follow the study protocol. Investigator and Outcomes Assessor will be blinded.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in brain activity [Baseline and 12 weeks]
MRI will be used to measure changes in brain activity during resting state, a working memory task, and executive function task.

Secondary Outcome Measures

Changes in cerebral blood flow [Baseline and 12 weeks]
MRI will be used to measure change in cerebral blood flow.
Changes in memory and executive function [Baseline and 12 weeks]
NIH Toolbox will be used to measure change in cognition throughout the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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