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Control diet was high in saturated fat from animal fats, common margarines, and shortenings.
Main outcome measures Death from all causes; association between changes in serum cholesterol and death; and coronary atherosclerosis and myocardial infarcts detected at autopsy.
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Design The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol.
Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators.
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Results The intervention group had significant reduction in serum cholesterol compared with controls (mean change from baseline −13.8% The traditional diet-heart hypothesis1 2 predicts that the serum cholesterol lowering effects of replacing saturated fat with vegetable oil rich in linoleic acid will diminish deposition of cholesterol in the arterial wall,3 4 slow progression of atherosclerosis,5 reduce coronary heart disease events, and improve survival.6 7 This diet-heart paradigm is supported by evidence from randomized controlled trials showing that replacement of saturated fat with linoleic acid lowers serum total cholesterol and low density lipoprotein8 9 10 11 12 and by observational evidence linking serum cholesterol to coronary heart disease events and deaths (fig 1).13 Despite these compelling relations, no randomized controlled trial has shown that replacement of saturated fat with linoleic acid significantly reduces coronary heart disease events or deaths (fig 1Fig 1 Traditional diet-heart hypothesis.