Table 1.
Summary of questions prespecified in Minnesota Coronary Experiment (MCE) and publication of results
| Question and study population(s) | Prior publication in peer reviewed manuscript15 | Analyses of recovered raw data in present manuscript |
|---|---|---|
| Did MCE intervention lower serum cholesterol? | ||
| ≥1 year cohort* | Published | Included |
| Prespecified subgroups | ─ | Included |
| Did MCE intervention reduce risk of death? | ||
| Full cohort | Published | Thesis† |
| Men and women‡ | Published | Thesis† |
| ≥65§ and <65 years | ─ | Thesis† |
| Primary and secondary prevention¶ | ─ | ─** |
| Was change in serum cholesterol related to risk of death? | ||
| ≥1 year cohort* | ─ | Included |
| Men and women‡ | ─ | Included |
| Age ≥65§ and <65 | ─ | Included |
| Primary and secondary prevention§ | ─ | ─** |
| Autopsy cohort | ||
| Did intervention reduce progression of aortic or coronary atherosclerosis? | ─ | Included†† |
| Did intervention reduce autopsy confirmed myocardial infarction? | ─ | Included†† |
| Did intervention reduce progression of atherosclerosis in circle of Willis (brain) or risk of stroke? | ─ | ─** |
*Serum cholesterol was measured only in subset of randomized participants with exposure to study diets for one year or longer.
†Raw data were not recovered; Kaplan Meier life tables included from 1981 Broste thesis.
‡MCE is only randomized controlled trial to test whether replacement of saturated fat with linoleic acid rich vegetable oil reduced coronary heart disease or death in women.
§MCE is larger of only two randomized controlled trials to test whether replacement of saturated fat with linoleic acid rich vegetable oil reduced coronary heart disease or death in older adults.
¶392 MCE participants had electrocardiographic evidence of current or prior myocardial infarction (pathological Q wave) at randomization.
**Raw data not recovered.
††Data recovered on 149/295 completed autopsies.