The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk

dc.contributor.authorSpiegelman, Donna
dc.contributor.authorLovato, Laura C.
dc.contributor.authorKhudyakov, Polyna
dc.contributor.authorWilkens, Trine L.
dc.contributor.authorAdebamowo, Clement A.
dc.contributor.authorAdebamowo, Sally N.
dc.contributor.authorAppel, Lawrence J.
dc.contributor.authorBeulens, Joline W.J.
dc.contributor.authorCoughlin, Janelle W.
dc.contributor.authorDragsted, Lars Ove
dc.contributor.authorEdenberg, Howard J.
dc.contributor.authorEriksen, Jane N.
dc.contributor.authorEstruch, Ramon
dc.contributor.authorGrobbee, Diederick E.
dc.contributor.authorGulayin, Pablo E.
dc.contributor.authorIrazola, Vilma
dc.contributor.authorKrystal, John H.
dc.contributor.authorLazo, Mariana
dc.contributor.authorMurray, Margaret M.
dc.contributor.authorRimm, Eric B.
dc.contributor.authorSchrieks, Ilse C.
dc.contributor.authorWilliamson, Jeff D.
dc.contributor.authorMukamal, Kenneth J.
dc.contributor.departmentBiochemistry and Molecular Biology, School of Medicineen_US
dc.date.accessioned2023-04-06T17:43:52Z
dc.date.available2023-04-06T17:43:52Z
dc.date.issued2020-12
dc.description.abstractBackground: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. Aim: The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. Methods: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. Results: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. Conclusions: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.en_US
dc.eprint.versionAuthor's manuscripten_US
dc.identifier.citationSpiegelman D, Lovato LC, Khudyakov P, et al. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. Eur J Prev Cardiol. 2020;27(18):1967-1982. doi:10.1177/2047487320912376en_US
dc.identifier.urihttps://hdl.handle.net/1805/32273
dc.language.isoen_USen_US
dc.publisherOxford University Pressen_US
dc.relation.isversionof10.1177/2047487320912376en_US
dc.relation.journalEuropean Journal of Preventive Cardiologyen_US
dc.rightsPublisher Policyen_US
dc.sourcePMCen_US
dc.subjectRandomized controlled trialen_US
dc.subjectEthanolen_US
dc.subjectCardiovascular diseasesen_US
dc.subjectDiabetes mellitus type 2en_US
dc.subjectGeriatricen_US
dc.titleThe Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risken_US
dc.typeArticleen_US
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