Alzheimer DiseaseNICENCT03841539
Nutrition Interventions for Cognitive Enhancement
A study testing Mediterranean Diet, Study Supplement and Low-fat Diet in people with Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Mediterranean Diet, Study Supplement and Low-fat Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Mediterranean Diet, Study Supplement, Low-fat Diet
- Keywords
- Cognitive Impairment, Dementia, Alzheimer Disease, Mediterranean Diet, Low Fat Diet
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
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 SupplementDietary supplement
Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
Low-fat DietBehavioural
Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Follow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian. Receives: Behavioral: Mediterranean Diet; Dietary Supplement: Study Supplement |
| Low-fat Diet | Active comparator | Follow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian. Receives: Dietary Supplement: Study Supplement; Behavioral: Low-fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months and 12 months
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
Change in total cholesterol
Measure of total cholesterol at baseline and 12 months
Measured: Baseline and 12 months
Change in HDL cholesterol
Measure of HDL cholesterol at baseline and 12 months
Measured: Baseline and 12 months
Change in total/HDL cholesterol ratio
Measure of total/HDL cholesterol ratio at baseline and 12 months
Measured: Baseline and 12 months
Change in LDL cholesterol
Measure of LDL cholesterol at baseline and 12 months
Measured: Baseline and 12 months
Change in triglycerides
Measure of triglycerides at baseline and 12 months
Measured: Baseline and 12 months
Change in apolipoprotein B
Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 months
Change in fasting glucose
Measure of glucose at baseline and 12 months
Measured: Baseline and 12 months
Change in Hemoglobin A1c (HbA1c)
Measure of HbA1c at baseline and 12 months
Measured: Baseline and 12 months
Change in Trimethylamine N-oxide (TMAO)
Measure of TMAO, a measure of cardiovascular disease risk, at baseline and 12 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 and 36 months
Measure of dietary adherence post intervention
Measure of dietary adherence through 3 day food records at 24 and 36 months
Measured: 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Mar 2019
- Primary completion15 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Debra K. Sullivan, PhD, RD, University of Kansas Medical Center
- Investigators
- Debra K Sullivan, PhD, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841539
- Sponsor's protocol ID
- STUDY00142752
- Other IDs
- 1R01AG060157-01
- Acronym
- NICE
- Status last verified
- Jun 2024
- First submitted
- 18 Jan 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Mediterranean Diet for Alzheimer's Disease Prevention
- ClinicalTrials.gov ID
- NCT03841539
- Acronym / sponsor ID
- NICE / STUDY00142752
- Conditions
- Alzheimer Disease
- Keywords
- Cognitive Impairment, Dementia, Alzheimer Disease, Mediterranean Diet, Low Fat Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to a dietary intervention; Mediterranean or Low-Fat, and will follow this eating pattern for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Behavioral: Mediterranean Diet, Dietary Supplement: Study SupplementFollow a Mediterranean eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian. |
| Low-fat Diet | Active comparator | Dietary Supplement: Study Supplement, Behavioral: Low-fat DietFollow a low-fat eating pattern and take a study supplement for one year. Dietary education will be provided by a Registered Dietitian. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietDiet 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. | Behavioural | Mediterranean Diet |
| Study SupplementRandomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo. | Dietary supplement | Low-fat Diet, Mediterranean Diet |
| Low-fat DietDiet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories. | Behavioural | Low-fat Diet |
Primary outcome
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.
29 secondary outcomes
Change in Verbal Memory Factor
Time frame: Baseline, 6 months and 12 months
Change in Visuospatial Processing Factor
Time frame: Baseline, 6 months and 12 months
Change in Attention Factor
Time frame: Baseline, 6 months and 12 months
Change in Executive Function Factor
Time frame: Baseline, 6 months and 12 months
Change in Speed of Processing Factor
Time frame: Baseline, 6 months and 12 months
Change in brain volume
Time frame: Baseline and 12 months
Change in cerebral antioxidant levels
Time frame: Baseline and 12 months
Change in blood pressure
Time frame: Baseline, 6 months and 12 months
Change in percentage of total fatty acids by weight
Time frame: Baseline and 12 months
Change in total cholesterol
Time frame: Baseline and 12 months
Change in HDL cholesterol
Time frame: Baseline and 12 months
Change in total/HDL cholesterol ratio
Time frame: Baseline and 12 months
Change in LDL cholesterol
Time frame: Baseline and 12 months
Change in triglycerides
Time frame: Baseline and 12 months
Change in apolipoprotein B
Time frame: Baseline and 12 months
Change in lipoprotein(a) (Lp(a))
Time frame: Baseline and 12 months
Change in high sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline and 12 months
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2)
Time frame: Baseline and 12 months
Change in insulin resistance score
Time frame: Baseline and 12 months
Change in fasting glucose
Time frame: Baseline and 12 months
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 12 months
Change in Trimethylamine N-oxide (TMAO)
Time frame: Baseline and 12 months
Change in a composite global cognition score post intervention
Time frame: 24 and 36 months
Change in Verbal Memory Factor post intervention
Time frame: 24 and 36 months
Change in Visuospatial Processing Factor post intervention
Time frame: 24 and 36 months
Change in Attention Factor post intervention
Time frame: 24 and 36 months
Change in Executive Function Factor post intervention
Time frame: 24 and 36 months
Change in Speed of Processing Factor post intervention
Time frame: 24 and 36 months
Measure of dietary adherence post intervention
Time frame: 24 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K Sullivan, PhD, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet, Study Supplement and Low-fat Diet in people with Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in a composite global cognition score (time frame: Baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.