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

NCT06137339 | Recruiting

• 1 other identifier: 00150975
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Aging

Keywords

Older Adults; Brain Health; Avocado; Brain Imaging; Cognition; Dietary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in cerebral blood flow

  Baseline and 12 weeks

• Changes in memory and executive function

  Baseline and 12 weeks

Study Arms (2)

Avocado Group

EXPERIMENTAL

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

No Diet Modification Group

NO INTERVENTION

Participants will continue their normal dietary pattern for 12 weeks and participate in 4 study visits.

Interventions

Avocado Group OTHER

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.

Avocado Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Avocado Nutrition Center: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Central Study Contacts

Emma Kelly, MS

CONTACT

913-588-7683; ekelly9@kumc.edu

Matthew Taylor, PhD

CONTACT

913-588-5363; mtaylor3@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants cannot be blinded to their allocation in order to follow the study protocol. Investigator and Outcomes Assessor will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Matthew K Taylor, PhD, RD

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

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: April 9, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)