Recruiting

AvoCog

Sponsor:

University of Kansas Medical Center

Code:

NCT06137339

Conditions

Brain Aging

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Avocado Group

Study Details

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

Study ID

NCT06137339

Start date

Apr 9, 2024

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: No Diet Modification Group

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

Interventions

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.

Primary outcome measure

  • Change in brain activity [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

Emma Kelly, MS

913-588-7683ekelly9@kumc.edu

Matthew Taylor, PhD

913-588-5363mtaylor3@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Emma Kelly, MS

913-588-7683ekelly9@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2024-08-22.