Status:
COMPLETED
Nutrition Interventions for Cognitive Enhancement
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
By doing this study, researchers hope to learn how the Mediterranean and low-fat eating patterns affect memory, brain volume, brain antioxidant status and cardio-metabolic biomarkers, such as blood pr...
Detailed Description
Participants will be randomized to either a Mediterranean or low-fat eating pattern. Participation in the study will last about 13 months. Each person will be prescribed one of two eating patterns for...
Eligibility Criteria
Inclusion
- Cognitively normal older adults ≥65 years (MMSE score ≥ 25; AD8 score of 2 or less; no prior diagnosis of MCI, AD or dementia; and not medically treated for cognitive impairment or dementia)
- Speak English as a primary language
- Be able to read and write in English
- Live in the Kansas City, Metropolitan area
- Body Mass Index (BMI) range between 20 - 40 kg/m2
Exclusion
- Serious medical risk, such as type 1 diabetes mellitus, cancer, recent cardiac event (e.g. heart attach, angioplasty)
- Taking the prescription drug Warfarin
- Taking a prescription fish oil, such as Lovaza, Omtryga, Vascepa, Epanova, etc., or prescribed a dose of over-the-counter (OTC) fish oil containing ≥300 mg Docohexanoic Acid (DHA) that cannot be adjusted to a lower dose
- Nut allergy, fish allergy (does not include shellfish)
- Adherence to specialized diet regimes (e.g., vegan, bariatric, renal, etc.) that make following either of the dietary plans impossible or unsafe
- Unwilling to be randomized to one of two diet interventions
- Evidence of severe major depression (GDS-SF ≥9) or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures
- Alcohol (over 3 drinks per day or total of 18 per week) or drug abuse, defined as the use of chemical substances (prescription, OTC or illegal drugs) in a pattern that can lead to an increased risk of problems and an inability to control the use of the substance
- Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, retirement community with reliance on dining facilities for meals)
- Already consuming a Mediterranean diet as determined using the 14-item MedD Assessment Tool (score of ≥8)
- Already consuming a low-fat diet as determined by the NCI Percentage Energy from Fat Screener (≤ 15% of calories from fat)
- Already participating in another research study
- Another member of household is already participating in this study
- Have a visual impairment that greatly diminishes ability to read or write
- Currently attempting to lose weight
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03841539
Start Date
March 7 2019
End Date
March 22 2023
Last Update
June 7 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160