- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841539
Nutrition Interventions for Cognitive Enhancement (NICE)
Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
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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.
Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
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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.
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Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 6 months and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months and 12 months
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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.
|
Baseline, 6 months and 12 months
|
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.
|
Baseline, 6 months and 12 months
|
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.
|
Baseline, 6 months and 12 months
|
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.
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Baseline, 6 months and 12 months
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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.
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Baseline and 12 months
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Change in cerebral antioxidant levels
Time Frame: Baseline and 12 months
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Antioxidant levels are measured in frontal and parietal regions of the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
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Baseline and 12 months
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Change in blood pressure
Time Frame: Baseline, 6 months and 12 months
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Measure of both systolic blood pressure and diastolic blood pressure at baseline, 6 months, and 12 months.
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Baseline, 6 months and 12 months
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Change in percentage of total fatty acids by weight
Time Frame: Baseline and 12 months
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Measure of red blood cell (RBC)-phospholipids at baseline and 12 months.
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Baseline and 12 months
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Change in total cholesterol
Time Frame: Baseline and 12 months
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Measure of total cholesterol at baseline and 12 months
|
Baseline and 12 months
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Change in HDL cholesterol
Time Frame: Baseline and 12 months
|
Measure of HDL cholesterol at baseline and 12 months
|
Baseline and 12 months
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Change in total/HDL cholesterol ratio
Time Frame: Baseline and 12 months
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Measure of total/HDL cholesterol ratio at baseline and 12 months
|
Baseline and 12 months
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Change in LDL cholesterol
Time Frame: Baseline and 12 months
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Measure of LDL cholesterol at baseline and 12 months
|
Baseline and 12 months
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Change in triglycerides
Time Frame: Baseline and 12 months
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Measure of triglycerides at baseline and 12 months
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Baseline and 12 months
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Change in apolipoprotein B
Time Frame: Baseline and 12 months
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Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months
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Baseline and 12 months
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Change in lipoprotein(a) (Lp(a))
Time Frame: Baseline and 12 months
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Measure of Lp(a), a measure of cardiovascular disease risk, at baseline and 12 months
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Baseline and 12 months
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Change in high sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline and 12 months
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Measure of hs-CRP, a measure of inflammation, at baseline and 12 months
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Baseline and 12 months
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Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)
Time Frame: Baseline and 12 months
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Measure of Lp-PLA2 activity, a measure of cardiovascular disease risk, at baseline and 12 months
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Baseline and 12 months
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Change in insulin resistance score
Time Frame: Baseline and 12 months
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Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months
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Baseline and 12 months
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Change in fasting glucose
Time Frame: Baseline and 12 months
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Measure of glucose at baseline and 12 months
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Baseline and 12 months
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Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline and 12 months
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Measure of HbA1c at baseline and 12 months
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Baseline and 12 months
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Change in Trimethylamine N-oxide (TMAO)
Time Frame: Baseline and 12 months
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Measure of TMAO, a measure of cardiovascular disease risk, at baseline and 12 months
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Baseline and 12 months
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Change in a composite global cognition score post intervention
Time Frame: 24 and 36 months
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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.
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24 and 36 months
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Change in Verbal Memory Factor post intervention
Time Frame: 24 and 36 months
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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
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.
|
24 and 36 months
|
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.
|
24 and 36 months
|
Change in Executive Function Factor post intervention
Time Frame: 24 and 36 months
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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
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.
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24 and 36 months
|
Measure of dietary adherence post intervention
Time Frame: 24 and 36 months
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Measure of dietary adherence through 3 day food records at 24 and 36 months
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24 and 36 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Debra K Sullivan, PhD, RD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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