AgingNCT06192407
Fatty Acid Modulation of Brain Function in Older Adults
A study testing High Oleic Acid Diet and High Palmitic Acid Diet in people with Aging, run by University of Vermont at 1 site in United States.
Trial summary
In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High Oleic Acid Diet and High Palmitic Acid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women age range 65-75 years
- Normal cognition (see Research Strategy for details on cognitive assessments)
- "Healthy" (body mass index (BMI) of 20-40 kg/m2)
Who cannot join
- Significant cognitive or behavioral impairment (see Research Strategy for testing and exclusions) or pharmacological treatment for this (e.g. antipsychotics, anxiolytics, and sedative medications).
- Hormone replacement therapy, past 3 months.
- Hyper-androgenic condition.
- HbA1C≥7.5% and or Fasting plasma glucose concentration ≥130 mg/dL.
- Type 2 Diabetes if receiving any other therapy than metformin.
- Use of nicotine or ingestion of caffeine or alcohol during the study.
Show all 11Show fewer
- Habitual fat intake < 25% of kcal or strict vegetarian diet.
- Sleep apnea requiring continuous positive airway pressure at night.
- Lung, cardiac (heart failure or its treatment), liver disease, renal disease, cancer, and any other medical disorder known or thought to cause inflammation or abnormalities of cognition
- Actively training for an athletic event or participating in competitive sports (such as league play or tournaments)
- Intolerance or allergy to any of the food provided in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05401
Jenna Makarewicz, B.S., 802-847-8248, jenna.makarewicz@uvmhealth.org
Julie Dumas, Ph.D., (802)847-2523, julie.dumas@uvm.edu
About this study
In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)/oleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA/OA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.
Read the detailed description
This study will examine how manipulating dietary fatty acids affects brain functioning in older adults. Prior studies have shown that there are behavioral changes that can be made to improve cognition in adults on an acute time scale including improving sleep and physical activity. Based on preclinical data and prior studies in humans the investigators propose that brain functioning also can be acutely improved with a reduction in dietary saturated fat. This approach will first be used in cognitively normal older adults without dementia, but in the future it may be that improving baseline cognition is beneficial in patients with mild cognitive impairment and Alzheimer's disease even if the overall course of the patient's neurological condition is increasingly impaired cognitive function.
The investigators will manipulate the dietary ratios of palmitic acid (PA) and oleic acid (OA), which are the most prevalent saturated and monounsaturated fatty acids, respectively in the diet and body lipids. Using a crossover study of men and women, aged 65-75 years, the investigators will administer two experimental diets in a random order for one week and each experimental diet will be preceded by a one-week, low fat control diet for a four-week total study period. One experimental diet will have a high PA/OA ratio typical of the usual North American Diet and the other experimental diet will have a low PA/OA ratio typical of the Mediterranean Diet. The following primary outcomes will be assessed: working memory performance, activation of working memory networks using functional magnetic resonance imaging (fMRI) and functional connectivity.
The impact of this study is that these data may suggest one mechanism for acutely improving cognition in healthy older adults and potentially in those with cognitive impairment such as mild cognitive impairment and Alzheimer's disease. While changing dietary behavior long term requires additional investigation, there are potential immediate benefits to acute improvements in cognition on quality of life for older adults.
- Conditions
- Aging
- Being tested
- High Oleic Acid Diet, High Palmitic Acid Diet
- Keywords
- fatty acids, diet, aging, MRI, palmitic acid, oleic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Oleic Acid DietDietary supplement
Also called HOA
Subjects are provided with all food for each meal every day. The food is low in fat. In addition, subjects are provided with an oil mix that is 100% hazelnut oil. They will be taught to consume the oil with each meal and mix it in with the food provided.
High Palmitic Acid DietDietary supplement
Also called HPA
Subjects are provided with all food for each meal every day. The food is low in fat. In addition, subjects are provided with an oil mix that is palm oil-89%, peanut oil-6.75%, and virgin olive oil-4.25%; . They will be taught to consume the oil with each meal and mix it in with the food provided.
| Study group | Role | What they receive |
|---|---|---|
| High Palmitic Acid Diet (HPA) | Experimental | Participants will ingest the HPA diet for one week. The saturated fatty acid will be high in palmitic acid which is the most prevalent saturated fatty acid in the American diet. The HPA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids. Receives: Dietary Supplement: High Palmitic Acid Diet |
| High Oleic Acid/Low Palmitic Acid Diet (HOA) | Experimental | Participants will ingest the HOA diet for one week. The monounsaturated fatty acid will be high in oleic acid which is the most prevalent monounsaturated fatty acid in the Mediterranean diet. The HOA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids. Receives: Dietary Supplement: High Oleic Acid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory Performance
Accuracy for performance on the Nback working memory test during fMRI
Measured: after 7 days of each diet
Working Memory Brain Activation
Blood Oxygen Level Dependent (BOLD) activation during the Nback working memory test during fMRI
Measured: after 7 days of each diet
Working Memory Brain Functional Connectivity
BOLD functional connectivity during resting state fMRI
Measured: after 7 days of each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Apr 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this crossover study, the investigators will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Dumas, University of Vermont
- Investigators
- Julie Dumas, Ph.D., Principal investigator, University of VermontCraig L Kien, MD, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192407
- Sponsor's protocol ID
- AG085286
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be acquired from 50 adults aged 65-75. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier will be collected for each subject. The specific data types are: From Screening: demographic, standard medical laboratory screening tests such as serum lipid concentrations, neuropsychological test scores, dual x-ray absorptiometry (DEXA) measurements, blood leptin. From the each of the 4 Study Days: unprocessed MRI data, processed MRI Brain Imaging Data Structure (BIDS) images, serum lipid concentrations, raw data from the Actigraph, processed sleep and activity data from the Actigraph measurements, daily stressors assessment, mood assessment, cognitive test scores.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Modulation of Brain Function in Older Adults
- ClinicalTrials.gov ID
- NCT06192407
- Acronym / sponsor ID
- AG085286
- Conditions
- Aging
- Keywords
- fatty acids, diet, aging, MRI, palmitic acid, oleic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 5 Jan 2024 (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.
In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)/oleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA/OA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.
Detailed description
This study will examine how manipulating dietary fatty acids affects brain functioning in older adults. Prior studies have shown that there are behavioral changes that can be made to improve cognition in adults on an acute time scale including improving sleep and physical activity. Based on preclinical data and prior studies in humans the investigators propose that brain functioning also can be acutely improved with a reduction in dietary saturated fat. This approach will first be used in cognitively normal older adults without dementia, but in the future it may be that improving baseline cognition is beneficial in patients with mild cognitive impairment and Alzheimer's disease even if the overall course of the patient's neurological condition is increasingly impaired cognitive function.
The investigators will manipulate the dietary ratios of palmitic acid (PA) and oleic acid (OA), which are the most prevalent saturated and monounsaturated fatty acids, respectively in the diet and body lipids. Using a crossover study of men and women, aged 65-75 years, the investigators will administer two experimental diets in a random order for one week and each experimental diet will be preceded by a one-week, low fat control diet for a four-week total study period. One experimental diet will have a high PA/OA ratio typical of the usual North American Diet and the other experimental diet will have a low PA/OA ratio typical of the Mediterranean Diet. The following primary outcomes will be assessed: working memory performance, activation of working memory networks using functional magnetic resonance imaging (fMRI) and functional connectivity.
The impact of this study is that these data may suggest one mechanism for acutely improving cognition in healthy older adults and potentially in those with cognitive impairment such as mild cognitive impairment and Alzheimer's disease. While changing dietary behavior long term requires additional investigation, there are potential immediate benefits to acute improvements in cognition on quality of life for older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this crossover study, the investigators will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period.
| Arm | Type | Receives |
|---|---|---|
| High Palmitic Acid Diet (HPA) | Experimental | Dietary Supplement: High Palmitic Acid DietParticipants will ingest the HPA diet for one week. The saturated fatty acid will be high in palmitic acid which is the most prevalent saturated fatty acid in the American diet. The HPA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids. |
| High Oleic Acid/Low Palmitic Acid Diet (HOA) | Experimental | Dietary Supplement: High Oleic Acid DietParticipants will ingest the HOA diet for one week. The monounsaturated fatty acid will be high in oleic acid which is the most prevalent monounsaturated fatty acid in the Mediterranean diet. The HOA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women age range 65-75 years
- Normal cognition (see Research Strategy for details on cognitive assessments)
- "Healthy" (body mass index (BMI) of 20-40 kg/m2)
Key exclusion criteria (11 listed)
- Significant cognitive or behavioral impairment (see Research Strategy for testing and exclusions) or pharmacological treatment for this (e.g. antipsychotics, anxiolytics, and sedative medications).
- Hormone replacement therapy, past 3 months.
- Hyper-androgenic condition.
- HbA1C≥7.5% and or Fasting plasma glucose concentration ≥130 mg/dL.
- Type 2 Diabetes if receiving any other therapy than metformin.
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 |
|---|---|---|
| High Oleic Acid DietAlso: HOASubjects are provided with all food for each meal every day. The food is low in fat. In addition, subjects are provided with an oil mix that is 100% hazelnut oil. They will be taught to consume the oil with each meal and mix it in with the food provided. | Dietary supplement | High Oleic Acid/Low Palmitic Acid Diet (HOA) |
| High Palmitic Acid DietAlso: HPASubjects are provided with all food for each meal every day. The food is low in fat. In addition, subjects are provided with an oil mix that is palm oil-89%, peanut oil-6.75%, and virgin olive oil-4.25%; . They will be taught to consume the oil with each meal and mix it in with the food provided. | Dietary supplement | High Palmitic Acid Diet (HPA) |
Primary outcome
Working Memory Performance
Time frame: after 7 days of each diet
Accuracy for performance on the Nback working memory test during fMRI
Working Memory Brain Activation
Time frame: after 7 days of each diet
Blood Oxygen Level Dependent (BOLD) activation during the Nback working memory test during fMRI
Working Memory Brain Functional Connectivity
Time frame: after 7 days of each diet
BOLD functional connectivity during resting state fMRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Data will be acquired from 50 adults aged 65-75. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier will be collected for each subject. The specific data types are: From Screening: demographic, standard medical laboratory screening tests such as serum lipid concentrations, neuropsychological test scores, dual x-ray absorptiometry (DEXA) measurements, blood leptin. From the each of the 4 Study Days: unprocessed MRI data, processed MRI Brain Imaging Data Structure (BIDS) images, serum lipid concentrations, raw data from the Actigraph, processed sleep and activity data from the Actigraph measurements, daily stressors assessment, mood assessment, cognitive test scores.
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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.
Julie Dumas, Ph.D. principal investigator
University of Vermont
Craig L Kien, MD, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Oleic Acid Diet and High Palmitic Acid Diet in people with Aging, run by University of Vermont 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Dumas, Ph.D. (1(802)847-2523, julie.dumas@uvm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory Performance (time frame: after 7 days of each diet). The study lists 3 primary outcomes in all. 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 4 Nov 2026.