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Purpose

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

Eligibility

Eligible Ages
Between 65 Years and 85 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Study participants will be randomly assigned equally to either the intervention or the control group.
Primary Purpose
Prevention
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Emma Kelly, MS
913-588-7683
ekelly9@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Emma Kelly, MS
913-588-7683
ekelly9@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.