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

NCT ID: NCT06137339

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-09

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Avocado Group

Intervention Type 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.

No Diet Modification Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avocado Nutrition Center

UNKNOWN

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Matthew Taylor

Dr. Matthew K Taylor, PhD, RD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emma Kelly, MS

Role: CONTACT

913-588-7683

Matthew Taylor, PhD

Role: CONTACT

913-588-5363

Facility Contacts

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Emma Kelly, MS

Role: primary

913-588-7683

Other Identifiers

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00150975

Identifier Type: -

Identifier Source: org_study_id

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