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NCT Number: NCT06137339

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.

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Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Emma Kelly, MS

CONTACT

[email protected]

913-588-7683

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in brain activity

    Time frame: 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 outcomes

  1. Changes in cerebral blood flow

    Time frame: Baseline and 12 weeks

    MRI will be used to measure change in cerebral blood flow.

  2. Changes in memory and executive function

    Time frame: Baseline and 12 weeks

    NIH Toolbox will be used to measure change in cognition throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Kelly, MS

CONTACT

[email protected]

913-588-7683

Matthew Taylor, PhD

CONTACT

[email protected]

913-588-5363

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Avocado Nutrition Center

Registry information

Acronym: AvoCog

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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