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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 Extavia (Interferon Beta-1b Kit)- FDA events, and improve survival.

Fig 1 Traditional diet-heart hypothesis. 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 Our recovery and 2013 publication of previously unpublished data from the Sydney Diet Heart St roche (SDHS, 1966-73) Extavia (Interferon Beta-1b Kit)- FDA showed that replacement of saturated fat with vegetable oil Extavia (Interferon Beta-1b Kit)- FDA in linoleic acid significantly increased the risks of death from coronary heart disease and all causes, despite lowering serum cholesterol.

The MCE is the only such randomized controlled trial to complete postmortem assessment of coronary, Extavia (Interferon Beta-1b Kit)- FDA, and cerebrovascular atherosclerosis grade Poliovirus Vaccine Inactivated (Ipol)- FDA infarct status and the only one to test the clinical Librium (Chlordiazepoxide)- FDA of increasing linoleic acid in large prespecified subgroups of women and older adults.

Further, to put these MCE findings into context, we conducted a systematic review and meta-analysis of all available randomized controlled trials that specifically tested whether replacement of saturated fat with linoleic acid rich oils reduces risk of death from coronary heart disease and all cause mortality.

The MCE was a double blinded, parallel group, randomized controlled dietary intervention trial, designed to evaluate the effects of increasing n-6 linoleic acid from corn oil in place of saturated fat for primary and secondary prevention of cardiovascular events and deaths, and for reducing the degree of coronary, aortic, and cerebrovascular atherosclerosis, and the number of myocardial infarcts and strokes detected at autopsy.

It was conducted from 1968 to 1973 in the state of Minnesota, United States. The experiment lasted from 41 to 56 months, depending on the hospital. The experiment was funded by the US Public Health Service and National Heart Institute through the R01 mechanism (HE 09686), with Ivan Frantz as principal investigator and Ancel Keys as co-principal investigator.

The MCE was approved by the clinical research committee of the University of Minnesota and by each of the seven collaborating hospitals. Residents were given the opportunity to decline participation. Non-participants were served the control diet and did not provide blood samples or undergo Extavia (Interferon Beta-1b Kit)- FDA. We were not able to recover a detailed description of the MCE autopsy consent procedure.

According to the 1989 publication, 42. No patients abbott laboratories on asked to advise on interpretation or writing up of results. There are no plans to disseminate the results of the research to study participants or the relevant patient community. Part 1 of the appendix describes the methods used to recover data, convert into a useable format, verify accuracy, and merge into a master file.

We call it Minnesota Coronary Experiment (MCE) to emphasize that we are using the experimental, randomized controlled trial phase of the MCS. In each of these documents, an emphasis was placed on total deaths, deaths from coronary heart disease, and non-fatal coronary heart disease events. The recovered documents did not contain a traditional sample size calculation.

This was likely because of the lack of a prespecified primary endpoint. We did recover multiple power calculations with different endpoints and assumptions, which provide ranges for adequate sample sizes. The randomized controlled trial phase was preceded by a 33 month pre-randomization Extavia (Interferon Beta-1b Kit)- FDA phase (February 1966 to November 1968), during johnson royals the study team characterized the hospital populations, developed and refined procedures for diet delivery, baseline and follow-up visits, sick visits, blood collection, electrocardiograms, and postmortem examination, as well as the data collection and management plans.

The experimental dietary intervention phase, which was initiated over a 15 month period according to start dates of hospital specific diets, lasted for Extavia (Interferon Beta-1b Kit)- FDA maximum of 56 months.

The start dates and duration of diet for each hospital are presented in table B in the appendix. Participants were followed up only while they were inpatients at the study hospitals. Participants case study were admitted to a given hospital after its respective diet phase was underway completed baseline risk assessment, electrocardiographic testing, and serum collection before they started the study diets.

Fig 3 Linoleic acid and saturated fat compositions of MCE control and intervention group diets. Values in figure are based on chemical analysis of study foods. Soft corn oil polyunsaturated margarine was used in place of butter. Hospital specific fatty acid compositions based on chemical analysis of a three week supply of study foods in 1971 are shown in part 1 of the appendix.

There was substantial variability in study diets Extavia (Interferon Beta-1b Kit)- FDA hospitals, with saturated fat ranging from 8. Saturated fat, however, was markedly reduced, and linoleic acid was markedly increased, in each hospital. It was designed to appear similar to the experimental diet. Notably, free surplus USDA food commodities including common margarines and shortenings were key components of the control diet, making the daily per participant allocation from the state of Minnesota adequate to cover the full costs.

This reduction, however, would be modest compared with the reduction in the intervention group. The original hospital inpatient population was randomized according to a stratified randomization scheme with 512 cells on the basis of eight variables (age, sex, length of stay in the hospital, weight, blood pressure, diabetes, cigarette smoking, and electrocardiographic evidence of previous myocardial infarction).

When new patients were admitted to a hospital after the diet start date, the stratified randomization scheme used four cells, according to age and sex. Study participants, the principal investigator, other study physicians, nurses, nutritionists, assistants, laboratory technicians, pathologists, and all other study staff were masked to group assignment.

Study foods were designed to appear similar in both groups. Both diets were served in a single line. Each study participant received his or her group specific food tray based on a unique computer generated code number, which was designed to be incomprehensible to the participants but easily interpreted by the food servers. Fifteen MCE forms were devised for recording the data from Extavia (Interferon Beta-1b Kit)- FDA hospitals and laboratories (appendix 2).

The data collected on these forms and the adherence data collected on the punch cards were transferred to magnetic tapes for later analysis. Serum cholesterol and triglyceride assays were performed according to the standard protocol of the Lipid Research Clinics15 26 in a laboratory standardized and monitored by the Center Extavia (Interferon Beta-1b Kit)- FDA Disease Control (Atlanta, GA).

MCE investigators hypothesized that the clinical effects of lowering serum cholesterol would take substantial time to manifest and thus placed special emphasis on the subgroup of participants exposed to the study diets for a year or more.

In addition to pre-randomization measures, participants had an average of six follow-up measurements of serum cholesterol. MCE investigators categorized fatal and non-fatal events into 10 categories (table C in the appendix). They used a conservative approach to attribute the cause of death to coronary heart disease.

Data on coronary heart disease deaths in relation to intermediate endpoints existed, however, and were reported in the 1981 Broste thesis. To our knowledge, however, no autopsy results have ever been published or reported.

According to the 1989 publication, 57. Hearts, aortas, and brains were sent to the University of Minnesota for blinded grading by university pathologists.

Extavia (Interferon Beta-1b Kit)- FDA recovered heart and aorta autopsy files for 149 out of these 295 completed autopsies.



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