NCT06192407 Fatty Acid Modulation of Brain Function in Older Adults
| NCT ID | NCT06192407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Vermont |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-15 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Julie Dumas, Ph.D.
PRINCIPAL INVESTIGATOR
University of Vermont
Frequently Asked Questions
Who can join the NCT06192407 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 75 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06192407 currently recruiting?
Yes, NCT06192407 is actively recruiting participants. Contact the research team at julie.dumas@uvm.com for enrollment information.
Where is the NCT06192407 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT06192407 clinical trial?
NCT06192407 is sponsored by University of Vermont. The principal investigator is Julie Dumas, Ph.D. at University of Vermont. The trial plans to enroll 60 participants.