Fatty Acid Modulation of Brain Function in Older Adults

NCT ID: NCT06192407

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2028-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

High Palmitic Acid Diet (HPA)

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.

Group Type: EXPERIMENTAL

High Palmitic Acid Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

High Oleic Acid/Low Palmitic Acid Diet (HOA)

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.

Group Type: EXPERIMENTAL

High Oleic Acid Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

High Oleic Acid Diet

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.

Intervention Type: DIETARY_SUPPLEMENT

High Palmitic Acid Diet

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

HOA; HPA

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Julie Dumas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Dumas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Craig L Kien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Dumas, Ph.D.

Role: CONTACT

julie.dumas@uvm.com

1(802)847-2523

Jenna Makarewicz, B.S.

Role: CONTACT

jenna.makarewicz@uvmhealth.org

1(802)847-8248

Facility Contacts

Jenna Makarewicz, B.S.

Role: primary

jenna.makarewicz@uvmhealth.org

(802)847-8248

Julie Dumas, Ph.D.

Role: backup

julie.dumas@uvm.edu

(802)847-2523

Other Identifiers

AG085286

Identifier Type: -

Identifier Source: org_study_id