Nutrition Interventions for Cognitive Enhancement (NICE)

Enhanced Mediterranean Diet for Alzheimer's Disease Prevention

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Mediterranean Diet; Dietary supplement: Study Supplement; Behavioral: Low-fat Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet; Follow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.	Behavioral: Mediterranean Diet; Diet consisting of fruits, vegetables, whole grains, low-fat dairy, olive oil, seafood, nuts and beans. It is low in red and processed meats, solid fats and added sugars.; Dietary supplement: Study Supplement; Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
Active Comparator: Low-fat Diet; Follow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.	Dietary supplement: Study Supplement; Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.; Behavioral: Low-fat Diet; Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in a composite global cognition score	Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and NIH Toolbox (NIH-TB) Cognition Battery and will be used to assess changes in a composite global cognition score at baseline, 6, and 12 months.	Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Verbal Memory Factor	Change in Verbal Memory Factor (derived from confirmatory factor analyses (CFA) of the following scales: Logical Memory I, Logical Memory II, and Selective Reminding Task) at baseline, 6 months and 12 months. CFA aggregates scores from across multiple subtests.	Baseline, 6 months and 12 months
Change in Visuospatial Processing Factor	Change in Visuospatial Processing Factor (derived from confirmatory factor analyses (CFA) of the following scales: Stroop Color Naming, Digit Symbol, Block Design, and Trailmaking A) at baseline, 6 months and 12 months. CFA aggregates scores from across multiple subtests.	Baseline, 6 months and 12 months
Change in Attention Factor	Change in Attention Factor (derived from confirmatory factor analyses (CFA) of the following scales: Digits Forward, Digits Backward, and Letter-Number Sequencing) at baseline, 6 months and 12 months. CFA aggregates scores from across multiple subtests.	Baseline, 6 months and 12 months
Change in Executive Function Factor	Change in Executive Function Factor (derived from confirmatory factor analyses (CFA) of the following scales: NIH-TB Dimensional Change Card Sort Test, NIH-TB Flanker Inhibitory Control and Attention Test, Trailmaking B, and Category Fluency) at baseline, 6 months and 12 months. CFA aggregates scores from across multiple subtests.	Baseline, 6 months and 12 months
Change in Speed of Processing Factor	Change in Speed of Processing Factor (derived from confirmatory factor analyses (CFA) of the following scales: of Crossing Off and NIH-TB Pattern Comparison Processing Speed Test) at baseline, 6 months and 12 months. CFA aggregates scores from across multiple subtests.	Baseline, 6 months and 12 months
Change in brain volume	Change in whole brain and hippocampal volume as assessed via magnetic resonance imaging (MRI) at baseline and 12 months.	Baseline and 12 months
Change in cerebral antioxidant levels	Antioxidant levels are measured in frontal and parietal regions of the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.	Baseline and 12 months
Change in blood pressure	Measure of both systolic blood pressure and diastolic blood pressure at baseline, 6 months, and 12 months.	Baseline, 6 months and 12 months
Change in percentage of total fatty acids by weight	Measure of red blood cell (RBC)-phospholipids at baseline and 12 months.	Baseline and 12 months
Change in total cholesterol	Measure of total cholesterol at baseline and 12 months	Baseline and 12 months
Change in HDL cholesterol	Measure of HDL cholesterol at baseline and 12 months	Baseline and 12 months
Change in total/HDL cholesterol ratio	Measure of total/HDL cholesterol ratio at baseline and 12 months	Baseline and 12 months
Change in LDL cholesterol	Measure of LDL cholesterol at baseline and 12 months	Baseline and 12 months
Change in triglycerides	Measure of triglycerides at baseline and 12 months	Baseline and 12 months
Change in apolipoprotein B	Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months	Baseline and 12 months
Change in lipoprotein(a) (Lp(a))	Measure of Lp(a), a measure of cardiovascular disease risk, at baseline and 12 months	Baseline and 12 months
Change in high sensitivity C-Reactive Protein (hs-CRP)	Measure of hs-CRP, a measure of inflammation, at baseline and 12 months	Baseline and 12 months
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)	Measure of Lp-PLA2 activity, a measure of cardiovascular disease risk, at baseline and 12 months	Baseline and 12 months
Change in insulin resistance score	Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months	Baseline and 12 months
Change in fasting glucose	Measure of glucose at baseline and 12 months	Baseline and 12 months
Change in Hemoglobin A1c (HbA1c)	Measure of HbA1c at baseline and 12 months	Baseline and 12 months
Change in Trimethylamine N-oxide (TMAO)	Measure of TMAO, a measure of cardiovascular disease risk, at baseline and 12 months	Baseline and 12 months
Change in a composite global cognition score post intervention	Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and NIH Toolbox (NIH-TB) Cognition Battery and will be used to assess changes in a composite global cognition score at 24 and 36 months.	24 and 36 months
Change in Verbal Memory Factor post intervention	Change in Verbal Memory Factor (derived from confirmatory factor analyses (CFA) of the following scales: Logical Memory I, Logical Memory II, and Selective Reminding Task) at 24 and 36 months. CFA aggregates scores from across multiple subtests.	24 and 36 months
Change in Visuospatial Processing Factor post intervention	Change in Visuospatial Processing Factor (derived from confirmatory factor analyses (CFA) of the following scales: Stroop Color Naming, Digit Symbol, Block Design, and Trailmaking A) at 24 and 36 months. CFA aggregates scores from across multiple subtests.	24 and 36 months
Change in Attention Factor post intervention	Change in Attention Factor (derived from confirmatory factor analyses (CFA) of the following scales: Digits Forward, Digits Backward, and Letter-Number Sequencing) at 24 and 36 months. CFA aggregates scores from across multiple subtests.	24 and 36 months
Change in Executive Function Factor post intervention	Change in Executive Function Factor (derived from confirmatory factor analyses (CFA) of the following scales: NIH-TB Dimensional Change Card Sort Test, NIH-TB Flanker Inhibitory Control and Attention Test, Trailmaking B, and Category Fluency) at 24 and 36 months. CFA aggregates scores from across multiple subtests.	24 and 36 months
Change in Speed of Processing Factor post intervention	Change in Speed of Processing Factor (derived from confirmatory factor analyses (CFA) of the following scales: of Crossing Off and NIH-TB Pattern Comparison Processing Speed Test) at 24 and 36 months. CFA aggregates scores from across multiple subtests.	24 and 36 months
Measure of dietary adherence post intervention	Measure of dietary adherence through 3 day food records at 24 and 36 months	24 and 36 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Debra K Sullivan, PhD, RD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Dementia; Alzheimer Disease; Mediterranean Diet; Low Fat Diet
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: STUDY00142752; 1R01AG060157-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No