RECRUITING

Fatty Acid Modulation of Brain Function in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Fatty Acid Modulation of Brain Function in Older Adults

Quick Facts

Study Start:2024-04-15
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06192407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women age range 65-75 years
  2. * Normal cognition (see Research Strategy for details on cognitive assessments)
  3. * "Healthy" (body mass index (BMI) of 20-40 kg/m2)
  1. * Significant cognitive or behavioral impairment (see Research Strategy for testing and exclusions) or pharmacological treatment for this (e.g. antipsychotics, anxiolytics, and sedative medications).
  2. * Hormone replacement therapy, past 3 months.
  3. * Hyper-androgenic condition.
  4. * HbA1C≥7.5% and or Fasting plasma glucose concentration ≥130 mg/dL.
  5. * Type 2 Diabetes if receiving any other therapy than metformin.
  6. * Use of nicotine or ingestion of caffeine or alcohol during the study.
  7. * Habitual fat intake \< 25% of kcal or strict vegetarian diet.
  8. * Sleep apnea requiring continuous positive airway pressure at night.
  9. * 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
  10. * Actively training for an athletic event or participating in competitive sports (such as league play or tournaments)
  11. * Intolerance or allergy to any of the food provided in the study.

Contacts and Locations

Study Contact

Julie Dumas, Ph.D.
CONTACT
1(802)847-2523
julie.dumas@uvm.com
Jenna Makarewicz, B.S.
CONTACT
1(802)847-8248
jenna.makarewicz@uvmhealth.org

Principal Investigator

Julie Dumas, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Vermont
Craig L Kien, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Vermont

Study Locations (Sites)

University of Vermont
Burlington, Vermont, 05401
United States

Collaborators and Investigators

Sponsor: University of Vermont

  • Julie Dumas, Ph.D., PRINCIPAL_INVESTIGATOR, University of Vermont
  • Craig L Kien, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Vermont

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2028-10-31

Terms related to this study

Keywords Provided by Researchers

  • fatty acids
  • diet
  • aging
  • MRI
  • palmitic acid
  • oleic acid

Additional Relevant MeSH Terms

  • Aging