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Nutrition Interventions for Cognitive Enhancement (NICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841539
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Mediterranean Diet Dietary Supplement: Study Supplement Behavioral: Low-fat Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to a dietary intervention; Mediterranean or Low-Fat, and will follow this eating pattern for 12 months.
Masking: Single (Outcomes Assessor)
Masking Description: Raters - (psychometrician, brain magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DEXA), and phlebotomy) will be blinded to the intervention group and will perform outcome assessments.
Primary Purpose: Prevention
Official Title: Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cognitively normal older adults over the age of 65 (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
  • 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
  • Nut allergy, fish allergy (does not include shellfish)
  • Adherence to specialized diet regimen (e.g., vegan, etc.)
  • Evidence of severe major depression (GDS-SF > 5) 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
  • Unwilling to be randomized to one of two diet interventions
  • 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 consume a Mediterranean diet
  • Already consume a low-fat diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841539


Contacts
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Contact: Juleah Littrell, MS, RD, LD 913-588-6392 jlittrell2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Juleah Littrell, MS, RD, LD         
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Debra K Sullivan, PhD, RD University of Kansas Medical Center
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Responsible Party: Debra K. Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03841539    
Other Study ID Numbers: STUDY00142752
1R01AG060157-01 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Debra K. Sullivan, PhD, RD, University of Kansas Medical Center:
Cognitive Impairment
Dementia
Alzheimer Disease
Mediterranean Diet
Low Fat Diet
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders