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Randomized Controlled Trial
. 2022 May:116:106728.
doi: 10.1016/j.cct.2022.106728. Epub 2022 Mar 12.

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

Pamela M Rist  1 , Howard D Sesso  2 , Lisa G Johnson  3 , Aaron K Aragaki  3 , Lu Wang  4 , Susanne Rautiainen  5 , Aditi Hazra  6 , Deirdre K Tobias  6 , Meryl S LeBoff  7 , Hagen Schroeter  8 , Georgina Friedenberg  6 , Trisha Copeland  6 , Allison Clar  6 , Lesley F Tinker  3 , Rebecca P Hunt  3 , Shari S Bassuk  6 , Ara Sarkissian  6 , Douglas C Smith  6 , Eduardo Pereira  6 , William R Carrick  3 , Emily S Wion  3 , Jennifer Schoenberg  3 , Garnet L Anderson  3 , JoAnn E Manson  9 ; COSMOS Research Group
Affiliations
Randomized Controlled Trial

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

Pamela M Rist et al. Contemp Clin Trials. 2022 May.

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.

Keywords: Cancer; Cardiovascular disease; Cocoa extract; Multivitamin; Randomized clinical trial.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs. Sesso and Manson reported receiving investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. Dr. Schroeter is employed by Mars Edge, a segment of Mars, Incorporated, a company engaged in flavanol research and flavanol-related commercial activities. No other disclosures were reported.

Figures

Figure 1.
Figure 1.
Recruitment and 2×2 factorial design for the COcoa Supplement and Multivitamin Outcomes Study (COSMOS)
Figure 2.
Figure 2.
Summary of COSMOS ancillary study participation.
See this image and copyright information in PMC

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