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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06137339
Other study ID # 00150975
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date December 2025

Study information

Verified date November 2023
Source University of Kansas Medical Center
Contact Emma Kelly, MS
Phone 913-588-7683
Email ekelly9@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center Avocado Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in cerebral blood flow MRI will be used to measure change in cerebral blood flow. Baseline and 12 weeks
Secondary Changes in memory and executive function NIH Toolbox will be used to measure change in cognition throughout the study. Baseline and 12 weeks
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