Nutrition Interventions for Cognitive Enhancement
NCT03841539, Not applicable, Completed, University of Kansas Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Nutrition Interventions for Cognitive Enhancement | ClinicalTrials.gov |
| NCT number | NCT03841539 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 209 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Kansas Medical Center | ClinicalTrials.gov |
| Conditions | Alzheimer Disease | ClinicalTrials.gov |
| Interventions | Mediterranean Diet, Study Supplement, Low-fat Diet | ClinicalTrials.gov |
| First posted | 2019-02-15 | ClinicalTrials.gov |
| Last updated | 2024-06-07 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in a composite global cognition score | 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. | ClinicalTrials.gov |
| Secondary | Change in Verbal Memory Factor | 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. | ClinicalTrials.gov |
| Secondary | Change in Visuospatial Processing Factor | 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. | ClinicalTrials.gov |
| Secondary | Change in Attention Factor | 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. | ClinicalTrials.gov |
| Secondary | Change in Executive Function Factor | 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. | ClinicalTrials.gov |
| Secondary | Change in Speed of Processing Factor | 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. | ClinicalTrials.gov |
| Secondary | Change in brain volume | Baseline and 12 months | Change in whole brain and hippocampal volume as assessed via magnetic resonance imaging (MRI) at baseline and 12 months. | ClinicalTrials.gov |
| Secondary | Change in cerebral antioxidant levels | 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. | ClinicalTrials.gov |
| Secondary | Change in blood pressure | Baseline, 6 months and 12 months | Measure of both systolic blood pressure and diastolic blood pressure at baseline, 6 months, and 12 months. | ClinicalTrials.gov |
| Secondary | Change in percentage of total fatty acids by weight | Baseline and 12 months | Measure of red blood cell (RBC)-phospholipids at baseline and 12 months. | ClinicalTrials.gov |
| Secondary | Change in total cholesterol | Baseline and 12 months | Measure of total cholesterol at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in HDL cholesterol | Baseline and 12 months | Measure of HDL cholesterol at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in total/HDL cholesterol ratio | Baseline and 12 months | Measure of total/HDL cholesterol ratio at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in LDL cholesterol | Baseline and 12 months | Measure of LDL cholesterol at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in triglycerides | Baseline and 12 months | Measure of triglycerides at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in apolipoprotein B | Baseline and 12 months | Measure of apolipoprotein B, a measure of cardiovascular disease risk, at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in lipoprotein(a) (Lp(a)) | Baseline and 12 months | Measure of Lp(a), a measure of cardiovascular disease risk, at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in high sensitivity C-Reactive Protein (hs-CRP) | Baseline and 12 months | Measure of hs-CRP, a measure of inflammation, at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) | Baseline and 12 months | Measure of Lp-PLA2 activity, a measure of cardiovascular disease risk, at baseline and 12 months | ClinicalTrials.gov |
| Secondary | Change in insulin resistance score | Baseline and 12 months | Measure of intact insulin and c-peptide to determine an insulin resistance score at baseline and 12 months | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG060157 | Enhanced Mediterranean Diet for Alzheimer's Disease Prevention | SULLIVAN, DEBRA K; BURNS, JEFFREY MURRAY | UNIVERSITY OF KANSAS MEDICAL CENTER | NATIONAL INSTITUTE ON AGING | 2018 to 2022 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Dimensional Change Card Sort | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Pattern and Letter Comparison | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)