Brain AgingAvoCogNCT06137339
AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults
A study testing Avocado Group in people with Brain Aging, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Aging
- What is being tested?
- Avocado Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Emma Kelly, MS, 913-588-7683, ekelly9@kumc.edu
About this study
Official title: 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.
- Conditions
- Brain Aging
- Being tested
- Avocado Group
- Keywords
- Older Adults, Brain Health, Avocado, Brain Imaging, Cognition, Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avocado GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Changes in cerebral blood flow
MRI will be used to measure change in cerebral blood flow.
Measured: Baseline and 12 weeks
Changes in memory and executive function
NIH Toolbox will be used to measure change in cognition throughout the study.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start9 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AgingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned equally to either the intervention or the control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Avocado Nutrition Center
- Responsible party
- Principal investigator, Matthew Taylor, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137339
- Sponsor's protocol ID
- 00150975
- Acronym
- AvoCog
- Status last verified
- Aug 2024
- First submitted
- 13 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AvoCog - The Effect of Daily Avocado Intake on Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT06137339
- Acronym / sponsor ID
- AvoCog / 00150975
- Conditions
- Brain Aging
- Keywords
- Older Adults, Brain Health, Avocado, Brain Imaging, Cognition, Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Avocado Nutrition Center
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants will be randomly assigned equally to either the intervention or the control group.
| Arm | Type | Receives |
|---|---|---|
| Avocado Group | Experimental | Other: Avocado GroupParticipants will consume 1 avocado per day and receive education to maintain usual caloric intake for 12 weeks and participate in 4 study visits. |
| No Diet Modification Group | No intervention | –Participants will continue their normal dietary pattern for 12 weeks and participate in 4 study visits. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avocado GroupParticipants 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. | Other | Avocado Group |
Primary outcome
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.
2 secondary outcomes
Changes in cerebral blood flow
Time frame: Baseline and 12 weeks
Changes in memory and executive function
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado Group in people with Brain Aging, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Kelly, MS (913-588-7683, ekelly9@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.