Evidence map›Paper›PMID 35288332›Full record

ArticleContemporary clinical trials2022

Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS).

Pamela M Rist, Howard D Sesso, Lisa G Johnson, Aaron K Aragaki, Lu Wang, Susanne Rautiainen, Aditi Hazra, Deirdre K Tobias, Meryl S LeBoff, Hagen Schroeter and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422745 (COcoa Supplement and Multivitamin Outcomes Study), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02422745 phase4completednot on this map

COcoa Supplement and Multivitamin Outcomes Study

TypeinterventionalSponsorBrigham and Women's HospitalRan2015 to 2023Enrolled21,442ConditionsCardiovascular Disease, CancerArmsCocoa extract, Multivitamin, Cocoa extract placebo, Multivitamin placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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  14. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 6 institutions in 2 countries.

Pamela M RistDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: prist@bwh.harvard.edu.
Howard D SessoDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: hsesso@bwh.harvard.edu.
Lisa G JohnsonDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Aaron K AragakiDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Lu WangEpidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.
Susanne RautiainenDepartment of Global Public Health, Karolinska Institute, Stockholm, Sweden.
Aditi HazraDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Deirdre K TobiasDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Meryl S LeBoffDivision of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Hagen SchroeterMars Inc., 6885 Elm St, McLean, VA 22101, USA.
Georgina FriedenbergDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Trisha CopelandDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Allison ClarDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Lesley F TinkerDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Rebecca P HuntDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Shari S BassukDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Ara SarkissianDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Douglas C SmithDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Eduardo PereiraDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
William R CarrickDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Emily S WionDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Jennifer SchoenbergDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Garnet L AndersonDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
JoAnn E MansonDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
COSMOS Research Group
Harvard University · USFred Hutch Cancer Center · USBrigham and Women's Hospital · USJanssen (United States) · USKarolinska Institutet · SEMars (United States) · US

Funding

WOMEN'S HEALTH INITIATIVE - CLINICAL COORDINATING CENTER: TASK AREA B - LONG LIFE STUDY VISIT 2 LIMITED HOME VISIT75N92021D00001 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ANDERSON, GARNET L. · 2021 to 2025
$52.0M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC): TASK AREA A AND A275N92021D00002 · NHLBI · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI WACTAWSKI-WENDE, JEAN · 2021 to 2025
$6.9M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00004 · NHLBI · STANFORD UNIVERSITY · PI STEFANICK, MARCIA · 2021 to 2025
$6.5M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00003 · NHLBI · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA · 2021 to 2025
$5.0M
WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC) - TO EXERCISE OPTION PERIOD ONE (1) AND REVISE CONTRACT ARTICLES.75N92021D00005 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI VITOLINS, MARA · 2021 to 2025
$4.2M
Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)R01AG050657 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BAKER, LAURA D., ESPELAND, MARK ANDREW · 2016 to 2020
$3.8M
Effect of randomized cocoa supplementation on inflammaging and epigenetic agingR01HL157665 · NHLBI · AUGUSTA UNIVERSITY · PI DONG, YANBIN, SESSO, HOWARD D · 2021 to 2024
$2.9M
COcoa Supplement and Multivitamins Outcomes Study (COSMOS): Effects on Falls and Physical PerformanceR01AG071611 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI CRANDALL, CAROLYN JANET, LEBOFF, MERYL SUSAN · 2021 to 2024
$2.7M
COSMOS Eye: Cataract and AMD in a Trial of a Multivitamin and Cocoa ExtractR01EY025623 · NEI · BRIGHAM AND WOMEN'S HOSPITAL · PI SESSO, HOWARD D · 2016 to 2020
$2.6M
NEI NIH HHS R01 EY025623NHLBI NIH HHS 75N92021D00001NHLBI NIH HHS 75N92021D00002NHLBI NIH HHS R01 HL157665NIA NIH HHS R01 AG050657NIA NIH HHS R01 AG071611WHI NIH HHS 75N92021D00003WHI NIH HHS 75N92021D00004WHI NIH HHS 75N92021D00005
6 · The paper itself

Abstract

Background Cocoa extract and multivitamins have been proposed to reduce the risk of cardiovascular disease (CVD) and cancer, respectively. However, few randomized clinical trials have tested their long-term effects on these outcomes. Methods The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of a cocoa extract supplement and a multivitamin supplement to reduce the risk of CVD and cancer. Here we describe the pragmatic, hybrid design of the trial and baseline characteristics of the trial participants. Results The nationwide study population includes 21,442 U.S. women aged ≥65 years and men aged ≥60 years without baseline myocardial infarction (MI), stroke, or a recent (within the past 2 years) cancer diagnosis. Participants were randomized in a 2 × 2 factorial design to one of four groups: (1) cocoa extract (containing 500 mg/d flavanols, including 80 mg (-)-epicatechin) and a multivitamin (Centrum Silver©); (2) cocoa extract and multivitamin placebo; (3) multivitamin and cocoa extract placebo; or (4) both placebos. Randomization successfully distributed baseline demographic, clinical, behavioral, and dietary characteristics across treatment groups. Baseline biospecimens were collected from 6867 participants, with at least one follow-up biospecimen from 2142 participants. The primary outcome for the cocoa extract intervention is total CVD (a composite of MI, stroke, cardiovascular mortality, coronary revascularization, unstable angina requiring hospitalization, carotid artery surgery, and peripheral artery surgery); the primary outcome for the multivitamin intervention is total invasive cancer. Conclusion COSMOS will provide important information on the health effects of cocoa extract and multivitamin supplementation in older U.S. adults. Clinical Trials Registration: clinicaltrials.gov #NCT02422745.

Indexed as

CacaoMyocardial InfarctionNeoplasmsStrokeAdultAgedDietary SupplementsDouble-Blind MethodFemaleHumansMaleMiddle AgedPlant ExtractsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicVitaminsPlant ExtractsVitaminsCancerCardiovascular diseaseCocoa extractMultivitaminRandomized clinical trial

Identifiers

PMID35288332
PMCPMC9133193
OpenAlexW4220791765

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.