Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03035201 · ClinicalTrials.gov registry record
COcoa Supplement and Multivitamin Outcomes Study for the Mind
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 2,262
- Enrollment target
NCT03035201: Completed study, sponsored by Wake Forest University Health Sciences.
NCT03035201 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 2,262 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03035201 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 2,262 participants
- Enrollment target
Study Summary
The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. A cognitive ancillary study (COSMOS-Mind) is being conducted among men and women, 65 years and older, who are enrolled in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improves cognitive function and reduces risk of cognitive impairment, including Alzheimer's disease (AD) and other related types of dementia. Participants at the Wake Forest site will only be getting a phone call.
Primary Outcome
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 primar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,262 participants |
| Start Date | 2016-09 |
| Est. Completion | 2021-02-12 |
What the finished NCT03035201 record still lists
NCT03035201 is an observational study that tracks outcomes without assigning an intervention. Its 2,262 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03035201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03035201 about?
NCT03035201 is a clinical study titled "COcoa Supplement and Multivitamin Outcomes Study for the Mind". The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascul...
What is the current status of trial NCT03035201?
This trial is currently completed. The enrollment target is 2,262 participants. The study started on 2016-09. Estimated completion is 2021-02-12.
Who is sponsoring clinical trial NCT03035201?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03968393 · 2,270 participants · Phase 4
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
- NCT04889872 · 2,250 participants · NA
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
- NCT06805513 · 2,250 participants · Phase 3
Actual Use Trial of Tadalafil 5 mg
- NCT06939803 · 2,236 participants · NA
AI-driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism: Study Protocol for the VTE-AI Randomized Trial.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia