COcoa Supplement and Multivitamin Outcomes Study for the Mind
NCT ID: NCT03035201
Last Updated: 2023-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
2262 participants
OBSERVATIONAL
2016-09-30
2021-02-12
Brief Summary
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Detailed Description
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The parent trial (COSMOS) will enroll 21,442 women and men nationwide, drawn from the Women's Health Initiative (WHI) participant cohort and the VITamin D and OmegA-3 TriaL (VITAL) non-randomized respondent cohort, and will be conducted primarily by mail to assess whether high-potency cocoa flavanol extract and a multivitamin - alone or in combination - will reduce risk of cardiovascular disease and cancer over 3 years of follow-up.
After the COSMOS trial began, an advanced method to analyze cocoa flavanols was accredited by Association of Official Agricultural Chemists (AOAC) International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132 \[secure-web.cisco.com\]). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to the COSMOS intervention, the total cocoa flavanol content of the COSMOS intervention is now 500 mg/day. Reporting of (-)-epicatechin content remained unaffected. Going forward, this record will therefore apply AOAC 2020.05/RM8403 and report that the COSMOS intervention tested 500 mg/day of cocoa flavanols, including 80 mg of (-)-epicatechin.
Once participants are enrolled in COSMOS, the study team at Brigham and Women's Hospital will provide contact information and other parent trial outcomes for COSMOS-Mind participants to the Wake Forest team using a secure web-based data transfer system. This seamless exchange of information between sites will permit timely accounting to ensure that the targeted demographics for enrollment are achieved (e.g. gender, age, race, ethnicity).
COSMOS-Mind will only be administered a telephone cognitive assessment to all participants at enrollment (baseline), and annually for 3 years of follow-up by trained and certified staff of the Wake Forest COSMOS-Mind team.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cocoa extract + multivitamin (MTV)
2 capsules containing 500 mg/d cocoa extract; daily MTV
No interventions assigned to this group
Cocoa extract + multivitamin placebo
2 capsules containing 500 mg/d cocoa extract; daily MTV placebo
No interventions assigned to this group
Cocoa extract placebo + multivitamin
Cocoa extract placebo (2 capsules/d); daily MTV
No interventions assigned to this group
Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo (2 capsules/d); daily MTV placebo
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Willingness to participate.
3. Ability to answer questions by phone.
Exclusion Criteria
2. Participants with insulin-dependent diabetes.
3. Participants who are unable to complete the baseline cognitive assessments.
65 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Brigham and Women's Hospital
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Laura D Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Mark A Espeland, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Stephen R Rapp, PhD
Role: PRINCIPAL_INVESTIGATOR
Co-Investigator Wake Forest School of Medicine
Sally A Shumaker, PhD
Role: PRINCIPAL_INVESTIGATOR
Co-Investigator Wake Forest School of Medicine
JoAnn E Manson, MD
Role: PRINCIPAL_INVESTIGATOR
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Howard Sesso, SCD, MPH
Role: PRINCIPAL_INVESTIGATOR
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Locations
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Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Countries
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References
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Vyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18.
Baker LD, Rapp SR, Shumaker SA, Manson JE, Sesso HD, Gaussoin SA, Harris D, Caudle B, Pleasants D, Espeland MA; COSMOS-Mind Research Group. Design and baseline characteristics of the cocoa supplement and multivitamin outcomes study for the Mind: COSMOS-Mind. Contemp Clin Trials. 2019 Aug;83:57-63. doi: 10.1016/j.cct.2019.06.019. Epub 2019 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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COcoa Supplement and Multivitamin Outcomes Study
Other Identifiers
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IRB00037753
Identifier Type: -
Identifier Source: org_study_id
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