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The results for two of these trials were not fully reported.Our recovery and 2013 publication of previously unpublished data from the Sydney Diet Heart Study (SDHS, 1966-73) belatedly showed that replacement of saturated fat with vegetable oil rich in linoleic acid significantly increased the risks of death from coronary heart disease and all causes, despite lowering serum cholesterol.14 Our recovery of unpublished documents and raw data from another diet-heart trial, the Minnesota Coronary Experiment, provided us with an opportunity to further evaluate this issue.
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Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators.
Further, a systematic review and meta-analyses of randomized controlled trials that lowered serum cholesterol by providing vegetable oil rich in linoleic acid in place of saturated fat without confounding by concomitant interventions was conducted.
Setting One nursing home and six state mental hospitals in Minnesota, United States.
Participants Unpublished documents with completed analyses for the randomized cohort of 9423 women and men aged 20-97; longitudinal data on serum cholesterol for the 2355 participants exposed to the study diets for a year or more; 149 completed autopsy files.
Interventions Serum cholesterol lowering diet that replaced saturated fat with linoleic acid (from corn oil and corn oil polyunsaturated margarine).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.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.Solid line indicates that causal relation has been established by randomized controlled trials (A); dashed lines indicate that no causal relation has been established (B and C).A=randomized controlled trials show that replacement of saturated fat with vegetable oils rich in linoleic acid lowers serum total cholesterol and LDL; B=intermediate endpoints related to serum cholesterol are robustly associated with risk of coronary heart disease events and deaths in observational studies; C= randomized controlled trials have tested whether replacement of saturated fat with linoleic acid reduces coronary heart disease events or deaths; none have shown significant benefit Only a handful of randomized controlled trials have ever causally tested the traditional diet-heart hypothesis.