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COcoa Supplement and Multivitamin Outcomes Study (COSMOS)

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ClinicalTrials.gov Identifier: NCT02422745
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Mars, Inc.
Pfizer
Columbia University
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is to determine whether taking daily, dietary supplements of cocoa extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard multivitamin reduces the risk of developing cardiovascular disease (including heart attack, stroke, coronary revascularization, and cardiovascular mortality) and cancer.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Cancer Dietary Supplement: Cocoa extract Dietary Supplement: Multivitamin Dietary Supplement: Cocoa extract placebo Dietary Supplement: Multivitamin placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21445 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: COcoa Supplement and Multivitamin Outcomes Study
Study Start Date : June 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cocoa extract + multivitamin Dietary Supplement: Cocoa extract
2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Dietary Supplement: Multivitamin
Multivitamin

Active Comparator: Cocoa extract + multivitamin placebo Dietary Supplement: Cocoa extract
2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Dietary Supplement: Multivitamin placebo
Multivitamin placebo

Active Comparator: Cocoa extract placebo + multivitamin Dietary Supplement: Multivitamin
Multivitamin

Dietary Supplement: Cocoa extract placebo
Cocoa extract placebo

Placebo Comparator: Cocoa extract placebo + multivitamin placebo Dietary Supplement: Cocoa extract placebo
Cocoa extract placebo

Dietary Supplement: Multivitamin placebo
Multivitamin placebo




Primary Outcome Measures :
  1. Cardiovascular disease (CVD) events [ Time Frame: 5 years ]
    CVD events include myocardial infarction, stroke, coronary revascularization procedures, and cardiovascular deaths. CVD events are confirmed by review of discharge summaries, ECG's, laboratory reports, test reports, and death certificates.

  2. Invasive cancer [ Time Frame: 5 years ]
    Diagnoses of invasive cancer are confirmed by review of discharge summaries, pathology reports, operative reports, and diagnostic or treatment procedure reports, including both inpatient and outpatient procedures.


Secondary Outcome Measures :
  1. Combined endpoint of major cardiovascular events plus all-cause mortality [ Time Frame: 5 years ]
  2. Myocardial infarction [ Time Frame: 5 years ]
  3. Stroke [ Time Frame: 5 years ]
  4. Cardiovascular mortality [ Time Frame: 5 years ]
  5. Coronary revascularization [ Time Frame: 5 years ]
  6. Total mortality [ Time Frame: 5 years ]
  7. Breast cancer [ Time Frame: 5 years ]
  8. Colorectal cancer [ Time Frame: 5 years ]
  9. Lung cancer [ Time Frame: 5 years ]
  10. Blood flavonoid levels [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Cognitive function [ Time Frame: 2-5 years ]
    Internet-based neuropsychological testing battery, including tests of novel object recognition, spatial learning, attention, inhibition, and executive control; face-to-face and computerized assessments of verbal memory, psychomotor speed, and executive function, working memory and organization; concentration and processing speed; visual recall; oral reading; receptive vocabulary; cognitive flexibility; attention; inhibitory control

  2. Systolic and diastolic blood pressure [ Time Frame: 2 years ]
  3. Pulse wave velocity and central blood pressure indices [ Time Frame: 2 years ]
    Assessed by pulse wave analysis

  4. Physical performance [ Time Frame: 2 years ]
    Balance tests, grip strength, timed chair stands, walking speed

  5. Bone mass density in hip, spine, and total body, and body composition [ Time Frame: 2 years ]
    Assessed by dual x-ray absorptiometry

  6. Body composition [ Time Frame: 2 years ]
  7. Metabolic and functional change within hippocampus [ Time Frame: 2 years ]
    Assessed with CBV MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women ≥ 65 years of age participating in the Women's Health Initiative (WHI) Extension Study.
  2. Men ≥ 60 years of age and women age ≥ 65 years of age who were contacted for but not randomized into the VITAL trial.
  3. Other women ≥ 65 years of age and men aged ≥ 60 years of age who responded to targeted mass mailings and volunteers who learned about the trial through the media or through ResearchMatch.org, an electronic recruitment website.
  4. Willing to participate, as evidenced by providing informed consent and completing all required baseline forms.

Exclusion Criteria:

  1. History of myocardial infarction or stroke.
  2. Diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to enrollment.
  3. Any serious illness that would preclude participation and/or completion of the trial, including the diagnosis of kidney failure and current dialysis treatment.
  4. Taking cocoa extract or multivitamin supplements and not willing to forego use during the trial.
  5. Taking total supplemental vitamin D > 1,000 IU/day and not willing to forego use during the trial.
  6. Taking total supplemental calcium > 1,200 mg/day and not willing to forego use during the trial.
  7. Extreme sensitivity to caffeine.
  8. Consume < 75% of the expected number of both types of supplements during the run-in phase.
  9. Unable to communicate in English due to language barrier or mental incapacity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422745


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Brigham and Women's Hospital
Fred Hutchinson Cancer Research Center
Mars, Inc.
Pfizer
Columbia University
Investigators
Principal Investigator: JoAnn E. Manson, MD Brigham and Women's Hospital

Additional Information:
Responsible Party: JoAnn E. Manson, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02422745     History of Changes
Other Study ID Numbers: 2014D001652
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Keywords provided by JoAnn E. Manson, MD, Brigham and Women's Hospital:
Cocoa extract multivitamins cardiovascular disease cancer

Additional relevant MeSH terms:
Cardiovascular Diseases