Nutrition Interventions for Cognitive Enhancement (NICE)
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About
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 pressure and blood glucose, in cognitively normal older adults. Researchers also plan to examine underlying processes relating the patterns to brain health.
Full 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 12 months. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian. Participants will engage in monthly food demonstrations and cooking classes. Participants will pick up a bag of food items belonging to the prescribed eating pattern, on a weekly basis for 6 months, from a local grocery store chain.
Participants have the option to continue in the study for up to 2 years for additional measurements.
Potential participants need to be located within the Kansas City metro area.
Enrollment
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Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
209 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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