MedTrace Logo

COcoa Supplement and Multivitamin Outcomes Study for the Mind

NCT03035201 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2262

Last updated 2023-08-22

Study results available
· View outcomes & findings →

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.

Conditions

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Brigham and Women's Hospital

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Laura D Baker, PhD · Wake Forest University Health Sciences

  • Mark A Espeland, PhD · Wake Forest University Health Sciences

  • Stephen R Rapp, PhD · Co-Investigator Wake Forest School of Medicine

  • Sally A Shumaker, PhD · Co-Investigator Wake Forest School of Medicine

  • JoAnn E Manson, MD · Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital

  • Howard Sesso, SCD, MPH · Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-02-12
Completion
2021-02-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035201 on ClinicalTrials.gov