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Completed

NCT Number: NCT03841539

Nutrition Interventions for Cognitive Enhancement

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Behavioral

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.

Study Supplement

Dietary Supplement

Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.

Low-Fat Diet

Behavioral

Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.

Primary outcomes

  1. Change in a composite global cognition score

    Time frame: Baseline, 6 months and 12 months

    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.

Secondary outcomes

  1. Change in Verbal Memory Factor

    Time frame: Baseline, 6 months and 12 months

    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.

  2. Change in Visuospatial Processing Factor

    Time frame: Baseline, 6 months and 12 months

    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.

  3. Change in Attention Factor

    Time frame: Baseline, 6 months and 12 months

    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.

  4. Change in Executive Function Factor

    Time frame: Baseline, 6 months and 12 months

    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.

  5. Change in Speed of Processing Factor

    Time frame: Baseline, 6 months and 12 months

    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.

  6. Change in brain volume

    Time frame: Baseline and 12 months

    Change in whole brain and hippocampal volume as assessed via magnetic resonance imaging (MRI) at baseline and 12 months.

  7. Change in cerebral antioxidant levels

    Time frame: Baseline and 12 months

    Antioxidant levels are measured in frontal and parietal regions of the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.

  8. Change in blood pressure

    Time frame: Baseline, 6 months and 12 months

    Measure of both systolic blood pressure and diastolic blood pressure at baseline, 6 months, and 12 months.

  9. Change in percentage of total fatty acids by weight

    Time frame: Baseline and 12 months

    Measure of red blood cell (RBC)-phospholipids at baseline and 12 months.

  10. Change in total cholesterol

    Time frame: Baseline and 12 months

    Measure of total cholesterol at baseline and 12 months

  11. Change in HDL cholesterol

    Time frame: Baseline and 12 months

    Measure of HDL cholesterol at baseline and 12 months

  12. Change in total/HDL cholesterol ratio

    Time frame: Baseline and 12 months

    Measure of total/HDL cholesterol ratio at baseline and 12 months

  13. Change in LDL cholesterol

    Time frame: Baseline and 12 months

    Measure of LDL cholesterol at baseline and 12 months

  14. Change in triglycerides

    Time frame: Baseline and 12 months

    Measure of triglycerides at baseline and 12 months

  15. Change in apolipoprotein B

    Time frame: Baseline and 12 months

    Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months

  16. Change in lipoprotein(a) (Lp(a))

    Time frame: Baseline and 12 months

    Measure of Lp(a), a measure of cardiovascular disease risk, at baseline and 12 months

  17. Change in high sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline and 12 months

    Measure of hs-CRP, a measure of inflammation, at baseline and 12 months

  18. Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)

    Time frame: Baseline and 12 months

    Measure of Lp-PLA2 activity, a measure of cardiovascular disease risk, at baseline and 12 months

  19. Change in insulin resistance score

    Time frame: Baseline and 12 months

    Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months

  20. Change in fasting glucose

    Time frame: Baseline and 12 months

    Measure of glucose at baseline and 12 months

  21. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline and 12 months

    Measure of HbA1c at baseline and 12 months

  22. Change in Trimethylamine N-oxide (TMAO)

    Time frame: Baseline and 12 months

    Measure of TMAO, a measure of cardiovascular disease risk, at baseline and 12 months

  23. Change in a composite global cognition score post intervention

    Time frame: 24 and 36 months

    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. Change in Verbal Memory Factor post intervention

    Time frame: 24 and 36 months

    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.

  25. Change in Visuospatial Processing Factor post intervention

    Time frame: 24 and 36 months

    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.

  26. Change in Attention Factor post intervention

    Time frame: 24 and 36 months

    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.

  27. Change in Executive Function Factor post intervention

    Time frame: 24 and 36 months

    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.

  28. Change in Speed of Processing Factor post intervention

    Time frame: 24 and 36 months

    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.

  29. Measure of dietary adherence post intervention

    Time frame: 24 and 36 months

    Measure of dietary adherence through 3 day food records at 24 and 36 months

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Enhanced Mediterranean Diet for Alzheimer's Disease Prevention

Acronym: NICE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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