Fatty Acid Modulation of Brain Function in Older Adults
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
September 17, 2025
September 1, 2025
4.3 years
December 9, 2023
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Working Memory Performance
Accuracy for performance on the Nback working memory test during fMRI
after 7 days of each diet
Working Memory Brain Activation
Blood Oxygen Level Dependent (BOLD) activation during the Nback working memory test during fMRI
after 7 days of each diet
Working Memory Brain Functional Connectivity
BOLD functional connectivity during resting state fMRI
after 7 days of each diet
Study Arms (2)
High Palmitic Acid Diet (HPA)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont
Burlington, Vermont, 05401, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Dumas, Ph.D.
University of Vermont
- PRINCIPAL INVESTIGATOR
Craig L Kien, MD, PhD
University of Vermont
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Each of the two experimental diets will be masked and only the dietician and statistician will be unblinded. Subjects will be assigned to one of two diet orders and the masking will be matched across the sexes.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2023
First Posted
January 5, 2024
Study Start
April 15, 2024
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- All data will be deposited at the Image \& Data Archive (IDA) run by the Laboratory of Neuro Imaging (LONI) at the University of Southern California (USC) Mark and Mary Stevens Neuroimaging and Informatics Institute starting 12 months after the award begins and will be deposited every six months thereafter. The research community will have access to data when the award ends. Data collections can be created that contain the data used for every publication. The IDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now. Nevertheless, the investigators will maintain thier own archive of the data for at least three years after the project ends.
- Access Criteria
- To request access to the data stored on the IDA, researchers will use the standard processes at the IDA which involves registering and creating an account. A data use application will be submitted along with the IDA registration and approved users will pe provided free access to the data.
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.