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Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online

NCT04582617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3959

Last updated 2023-04-07

No results posted yet for this study

Summary

The 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 (-)-epicatechin), and/or 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. This ancillary study (COSMOS Web) is being conducted among a subset of participants in COSMOS and will examine whether the cocoa extract supplements affects cognitive function in older adults.

Conditions

  • Aging
  • Cognitive Change

Interventions

DIETARY_SUPPLEMENT

Cocoa Extract

2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

DIETARY_SUPPLEMENT

Cocoa Extract Placebo

Cocoa extract placebo

DIETARY_SUPPLEMENT

Multivitamin

Multivitamin

DIETARY_SUPPLEMENT

Multivitamin placebo

Multivitamin placebo

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Mars, Inc.

    collaborator INDUSTRY

  • Columbia University

    lead OTHER

Principal Investigators

  • Adam M. Brickman, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-26
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04582617 on ClinicalTrials.gov