Trial · NCT03035201
COcoa Supplement and Multivitamin Outcomes Study for the Mind
NCT03035201, Completed, Wake Forest University Health Sciences; results first posted 2023-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. COcoa Supplement and Multivitamin Outcomes Study for the Mind. Trials, record NCT03035201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03035201
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COcoa Supplement and Multivitamin Outcomes Study for the Mind
- NCT number
- NCT03035201
- Status
- Completed
- Enrollment
- 2,262 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Cognitive Impairment, Dementia, Aging
- First posted
- 2017-01-27
- Last updated
- 2023-08-22
- Results first posted
- 2023-08-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Global Cognitive Function: Average Change Over Follow-up From Baseline | From Baseline through Year 3 | A composite cognitive measure that averages individual test z-scores of the Telephone Interview for Cognitive Status-modified (TICSm) Total and Long, the Immediate and Delayed Story Recall tests, the Oral Trail Making A and B tests (log-transformed), the Category Fluency and Verbal Fluency tests, and the Number Span Backward and Forward tests. Scores are ordered so that better performance corresponds to higher positive scores. Longitudinal data are used to create a linear contrast for the primary analysis to compare the difference between the average of scores at Years 1, 2, and 3 and the baseline score, i.e. (z1+z2+z3)/3 - z0, where z's denote the composited measures at baseline and years 1-3. This contrast is fitted using a random effects model for repeated measures. The primary comparison is for the margins of the factorial design: active cocoa flavonal (with or without active multivitamin) versus placebo flavonal (with or without active multivitamin). |
| Secondary | Composite Cognitive Function | From baseline through year 3 | A composite cognitive measure that averages individual test z-scores of the Telephone Interview for Cognitive Status-modified (TICSm) Total and Long, the Immediate and Delayed Story Recall tests, the Oral Trail Making A and B tests (log-transformed), the Category Fluency and Verbal Fluency tests, and the Number Span Backward and Forward tests. Scores are ordered so that better performance corresponds to higher positive scores. Longitudinal data are used to create a linear contrast for the primary analysis to compare the difference between the average of scores at Years 1, 2, and 3 and the baseline score, i.e. (z1+z2+z3)/3 - z0, where z's denote the composited measures at baseline and years 1-3. This contrast is fitted using a random effects model for repeated measures. The comparison for this secondary outcome is based on the margins of the factorial design to compare multivitamin (with or without cocoa flavonal) with multivitamin placebo (with or without cocoa flavonal) |
| Secondary | Incident Mild Cognitive Impairment | From baseline through year 3 | Mild cognitive impairment based on centralized adjudication of cognitive test scores and input from a proxy. Limited to participants free of mild cognitive impairment at baseline. Incidence over 3 years of follow-up. |
| Secondary | Incidence of Mild Cognitive Impairment Among Those Free at Baseline | From baseline through year 3 | Mild cognitive impairment based on central adjudication of test scores with input from proxies. Based on test scores administered annually across 3 years. |
| Secondary | Executive Function | From baseline through year 3 | Average of z-scores for the following tests: Oral Trail Making Test - B (log-transformed), Category Verbal Fluency, Letter Verbal Fluency, Number Span Test (Backwards and Forward). Higher (positive) scores reflect better performance. Linear contrast of scores collected at baseline, year 1, year 2, and year 3: (z1+z2+z3)/3 - z0) |
| Secondary | Episodic Memory | From baseline through year 3 | Average z-scores from Telephone Interview for Cognitive Status-modified Delayed Word List, Story Immediate Recall, Story Delayed Recall. Higher (positive) scores reflect better performance. Annual test administrations. |
| Secondary | Executive Function | From baseline through year 3 | Average of z-scores for the following tests: Oral Trail Making Test - B (log-transformed), Category Verbal Fluency, Letter Verbal Fluency, Number Span Test (Backwards and Forward). Higher (positive) scores reflect better performance. Tests administered annually. |
| Secondary | Episodic Memory | From baseline through year 3 | Average z-scores from Telephone Interview for Cognitive Status-modified Delayed Word List, Story Immediate Recall, Story Delayed Recall. Higher (positive) scores reflect better performance. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Global Cognitive Function: Average Change Over Follow-up From Baseline | From Baseline through Year 3 | Intention to treat -- All enrolled participants | score on a scale | MEAN |
| SECONDARY | Composite Cognitive Function | From baseline through year 3 | Complete randomized cohort | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Incident Mild Cognitive Impairment | From baseline through year 3 | Limited to participants free of mild cognitive impairment at baseline. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Mild Cognitive Impairment Among Those Free at Baseline | From baseline through year 3 | Participants free of mild cognitive impairment at baseline. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Executive Function | From baseline through year 3 | All randomized participants. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Episodic Memory | From baseline through year 3 | In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Executive Function | From baseline through year 3 | All randomized participants. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Episodic Memory | From baseline through year 3 | All randomized participants. In a factorial design such as this, primary comparisons are cocoa flavanol vs cocoa flavanol placebo (pooling across multivitamin and multivitamin placebo) and multivitamin vs multivitamin placebo (pooling across cocoa flavanol and cocoa flavanol placebo). To provide outcomes for the four cells does not conform with the protocol or the published results and will not be consistent with the statistical analysis plan. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Global Cognitive Function: Average Change Over Follow-up From Baseline | Cocoa Extract + Multivitamin | 0.24 | Standard Error 0.02 | score on a scale | |
| Global Cognitive Function: Average Change Over Follow-up From Baseline | Cocoa Extract + Multivitamin Placebo | 0.15 | Standard Error 0.02 | score on a scale | |
| Global Cognitive Function: Average Change Over Follow-up From Baseline | Cocoa Extract Placebo + Multivitamin | 0.20 | Standard Error 0.02 | score on a scale | |
| Global Cognitive Function: Average Change Over Follow-up From Baseline | Cocoa Extract Placebo + Multivitamin Placebo | 0.15 | Standard Error 0.02 | score on a scale | |
| Composite Cognitive Function | Cocoa Extract + Multivitamin | 0.24 | Standard Error 0.02 | score on a scale | |
| Composite Cognitive Function | Cocoa Extract + Multivitamin Placebo | 0.15 | Standard Error 0.02 | score on a scale | |
| Composite Cognitive Function | Cocoa Extract Placebo + Multivitamin | 0.20 | Standard Error 0.02 | score on a scale | |
| Composite Cognitive Function | Cocoa Extract Placebo + Multivitamin Placebo | 0.15 | Standard Error 0.02 | score on a scale | |
| Incident Mild Cognitive Impairment | Cocoa Extract | 47 | Participants | ||
| Incident Mild Cognitive Impairment | Cocoa Extract Placebo | 63 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cocoa Extract + Multivitamin | 571 | |
| Overall Study | STARTED | Cocoa Extract + Multivitamin Placebo | 553 | |
| Overall Study | STARTED | Cocoa Extract Placebo + Multivitamin | 551 | |
| Overall Study | STARTED | Cocoa Extract Placebo + Multivitamin Placebo | 587 | |
| Overall Study | COMPLETED | Cocoa Extract + Multivitamin | 444 | |
| Overall Study | COMPLETED | Cocoa Extract + Multivitamin Placebo | 441 | |
| Overall Study | COMPLETED | Cocoa Extract Placebo + Multivitamin | 441 | |
| Overall Study | COMPLETED | Cocoa Extract Placebo + Multivitamin Placebo | 462 | |
| Overall Study | NOT COMPLETED | Cocoa Extract + Multivitamin | 127 | |
| Overall Study | NOT COMPLETED | Cocoa Extract + Multivitamin Placebo | 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cocoa Extract + Multivitamin | 0 | 0 |
| Total, all-cause mortality | Cocoa Extract + Multivitamin Placebo | 0 | 0 |
| Total, all-cause mortality | Cocoa Extract Placebo + Multivitamin | 0 | 0 |
| Total, all-cause mortality | Cocoa Extract Placebo + Multivitamin Placebo | 0 | 0 |
| Total, other adverse events | Cocoa Extract + Multivitamin | 0 | 0 |
| Total, other adverse events | Cocoa Extract + Multivitamin Placebo | 0 | 0 |
| Total, other adverse events | Cocoa Extract Placebo + Multivitamin | 0 | 0 |
| Total, other adverse events | Cocoa Extract Placebo + Multivitamin Placebo | 0 | 0 |
| Total, serious adverse events | Cocoa Extract + Multivitamin | 0 | 0 |
| Total, serious adverse events | Cocoa Extract + Multivitamin Placebo | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| R01AG050657 | Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind) | BAKER, LAURA D.; ESPELAND, MARK ANDREW | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON AGING | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cocoa Extract vs Cocoa Extract Placebo: Incident Mild Cognitive Impairment | Trial comparisons |
| Multivitamin vs Multivitamin Placebo: Incidence of Mild Cognitive Impairment Among Those Free at Baseline | Trial comparisons |
Tests5
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 | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03035201
GET https://conductscience.org/api/trials/v1/NCT03035201/registered