Comparison · NCT03035201-62978d02
Cocoa Extract vs Cocoa Extract Placebo: Incident Mild Cognitive Impairment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cocoa Extract vs Cocoa Extract Placebo: Incident Mild Cognitive Impairment. Trial comparisons, record NCT03035201-62978d02. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03035201-62978d02
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0513 | 0.0388 | 0.0676 | wilson | |
| Risk in group 2 | 0.067 | 0.0527 | 0.0848 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0157 | -0.0375 | 0.00593 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.766 | 0.531 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.753 | 0.51 | 1.11 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cocoa Extract than on Cocoa Extract Placebo | 63.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cocoa Extract | Daily cocoa extract (capsule containing 750 mg/d flavanols, including 75 mg (-)-epicatechin, and 90 mg theobromine) | 47 | 916 | OG000 |
| Group 2 | Cocoa Extract Placebo | Daily cocoa extract placebo | 63 | 940 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incident Mild Cognitive Impairment
- Description
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.
- Time frame
- From baseline through year 3
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- COcoa Supplement and Multivitamin Outcomes Study for the Mind
- NCT number
- NCT03035201
- Phases
- Conditions
- Cognitive Impairment, Dementia, Aging
- Interventions
- Lead sponsor
- Wake Forest University Health Sciences
- Results first posted
- 2023-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03035201?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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