Clinical trial NCT03841539: Nutrition Interventions for Cognitive Enhancement
Official title: Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Cognitive Impairment
Dementia
Alzheimer Disease
Mediterranean Diet
Low Fat Diet
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-02-15
Enrollment: 209
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to a dietary intervention; Mediterranean or Low-Fat, and will follow this eating pattern for 12 months.
Primary purpose: PREVENTION

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 pressure and blood glucose, in cognitively normal older adults. Researchers also plan to examine underlying processes relating the patterns to brain health.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in a composite global cognition score
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change in Verbal Memory Factor
timeFrame: Baseline, 6 months and 12 months
measure: Change in Visuospatial Processing Factor
timeFrame: Baseline, 6 months and 12 months
measure: Change in Attention Factor
timeFrame: Baseline, 6 months and 12 months
measure: Change in Executive Function Factor
timeFrame: Baseline, 6 months and 12 months
measure: Change in Speed of Processing Factor
timeFrame: Baseline, 6 months and 12 months
measure: Change in brain volume
timeFrame: Baseline and 12 months
measure: Change in cerebral antioxidant levels
timeFrame: Baseline and 12 months
measure: Change in blood pressure
timeFrame: Baseline, 6 months and 12 months
measure: Change in percentage of total fatty acids by weight
timeFrame: Baseline and 12 months
measure: Change in total cholesterol
timeFrame: Baseline and 12 months
measure: Change in HDL cholesterol
timeFrame: Baseline and 12 months
measure: Change in total/HDL cholesterol ratio
timeFrame: Baseline and 12 months
measure: Change in LDL cholesterol
timeFrame: Baseline and 12 months
measure: Change in triglycerides
timeFrame: Baseline and 12 months
measure: Change in apolipoprotein B
timeFrame: Baseline and 12 months
measure: Change in lipoprotein(a) (Lp(a))
timeFrame: Baseline and 12 months
measure: Change in high sensitivity C-Reactive Protein (hs-CRP)
timeFrame: Baseline and 12 months
measure: Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)
timeFrame: Baseline and 12 months
measure: Change in insulin resistance score
timeFrame: Baseline and 12 months
measure: Change in fasting glucose
timeFrame: Baseline and 12 months
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and 12 months
measure: Change in Trimethylamine N-oxide (TMAO)
timeFrame: Baseline and 12 months
measure: Change in a composite global cognition score post intervention
timeFrame: 24 and 36 months
measure: Change in Verbal Memory Factor post intervention
timeFrame: 24 and 36 months
measure: Change in Visuospatial Processing Factor post intervention
timeFrame: 24 and 36 months
measure: Change in Attention Factor post intervention
timeFrame: 24 and 36 months
measure: Change in Executive Function Factor post intervention
timeFrame: 24 and 36 months
measure: Change in Speed of Processing Factor post intervention
timeFrame: 24 and 36 months
measure: Measure of dietary adherence post intervention
timeFrame: 24 and 36 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Debra K Sullivan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: