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Nutrition Interventions for Cognitive Enhancement (NICE)

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Diet
Study Supplement
Low-fat Diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Cognitive Impairment, Dementia, Alzheimer Disease, Mediterranean Diet, Low Fat Diet

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean Diet

Low-fat Diet

Arm Description

Follow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.

Follow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change in brain volume
Change in whole brain and hippocampal volume as assessed via magnetic resonance imaging (MRI) at 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.
Change in blood pressure
Measure of both systolic blood pressure and diastolic blood pressure at 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.
Change in total cholesterol
Measure of total cholesterol at baseline and 12 months
Change in HDL cholesterol
Measure of HDL cholesterol at baseline and 12 months
Change in total/HDL cholesterol ratio
Measure of total/HDL cholesterol ratio at baseline and 12 months
Change in LDL cholesterol
Measure of LDL cholesterol at baseline and 12 months
Change in triglycerides
Measure of triglycerides at baseline and 12 months
Change in apolipoprotein B
Measure of apolipoprotein B, a measure of cardiovascular disease risk, at 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
Change in high sensitivity C-Reactive Protein (hs-CRP)
Measure of hs-CRP, a measure of inflammation, at 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
Change in insulin resistance score
Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months
Change in fasting glucose
Measure of glucose at baseline and 12 months
Change in Hemoglobin A1c (HbA1c)
Measure of HbA1c at baseline and 12 months
Change in Trimethylamine N-oxide (TMAO)
Measure of TMAO, a measure of cardiovascular disease risk, at 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.
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.
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.
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.
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.
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.
Measure of dietary adherence post intervention
Measure of dietary adherence through 3 day food records at 24 and 36 months

Full Information

First Posted
January 18, 2019
Last Updated
June 16, 2022
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03841539
Brief Title
Nutrition Interventions for Cognitive Enhancement
Acronym
NICE
Official Title
Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Cognitive Impairment, Dementia, Alzheimer Disease, Mediterranean Diet, Low Fat Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to a dietary intervention; Mediterranean or Low-Fat, and will follow this eating pattern for 12 months.
Masking
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.
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Follow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.
Arm Title
Low-fat Diet
Arm Type
Active Comparator
Arm Description
Follow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Study Supplement
Intervention Description
Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
Intervention Type
Behavioral
Intervention Name(s)
Low-fat Diet
Intervention Description
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 Measure Information:
Title
Change in a composite global cognition score
Description
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.
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in Verbal Memory Factor
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in Visuospatial Processing Factor
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in Attention Factor
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in Executive Function Factor
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in Speed of Processing Factor
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in brain volume
Description
Change in whole brain and hippocampal volume as assessed via magnetic resonance imaging (MRI) at baseline and 12 months.
Time Frame
Baseline and 12 months
Title
Change in cerebral antioxidant levels
Description
Antioxidant levels are measured in frontal and parietal regions of the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Time Frame
Baseline and 12 months
Title
Change in blood pressure
Description
Measure of both systolic blood pressure and diastolic blood pressure at baseline, 6 months, and 12 months.
Time Frame
Baseline, 6 months and 12 months
Title
Change in percentage of total fatty acids by weight
Description
Measure of red blood cell (RBC)-phospholipids at baseline and 12 months.
Time Frame
Baseline and 12 months
Title
Change in total cholesterol
Description
Measure of total cholesterol at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in HDL cholesterol
Description
Measure of HDL cholesterol at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in total/HDL cholesterol ratio
Description
Measure of total/HDL cholesterol ratio at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in LDL cholesterol
Description
Measure of LDL cholesterol at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in triglycerides
Description
Measure of triglycerides at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in apolipoprotein B
Description
Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in lipoprotein(a) (Lp(a))
Description
Measure of Lp(a), a measure of cardiovascular disease risk, at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in high sensitivity C-Reactive Protein (hs-CRP)
Description
Measure of hs-CRP, a measure of inflammation, at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)
Description
Measure of Lp-PLA2 activity, a measure of cardiovascular disease risk, at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in insulin resistance score
Description
Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in fasting glucose
Description
Measure of glucose at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in Hemoglobin A1c (HbA1c)
Description
Measure of HbA1c at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in Trimethylamine N-oxide (TMAO)
Description
Measure of TMAO, a measure of cardiovascular disease risk, at baseline and 12 months
Time Frame
Baseline and 12 months
Title
Change in a composite global cognition score post intervention
Description
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.
Time Frame
24 and 36 months
Title
Change in Verbal Memory Factor post intervention
Description
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.
Time Frame
24 and 36 months
Title
Change in Visuospatial Processing Factor post intervention
Description
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.
Time Frame
24 and 36 months
Title
Change in Attention Factor post intervention
Description
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.
Time Frame
24 and 36 months
Title
Change in Executive Function Factor post intervention
Description
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.
Time Frame
24 and 36 months
Title
Change in Speed of Processing Factor post intervention
Description
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.
Time Frame
24 and 36 months
Title
Measure of dietary adherence post intervention
Description
Measure of dietary adherence through 3 day food records at 24 and 36 months
Time Frame
24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra K Sullivan, PhD, RD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition Interventions for Cognitive Enhancement

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