The role of nutrition-related clinical trials in informing dietary recommendations for health and treatment of diseases.

Dietary guidance is based on a robust evidence base that includes high-quality clinical trials, of which some have been designed to establish causal relationships between dietary interventions and ASCVD risk reduction. However, the complexity associated with conducting these trials has resulted in criticism of nutrition and dietary recommendations because the strength and quality of evidence falls short of that for some pharmaceutical interventions. In this paper, we aim to promote greater awareness of the nutrition-related clinical trials that have been conducted showing ASCVD benefits and how this evidence has contributed to dietary recommendations.

ApoA-I Infusions and Burden of Ischemic Events After Acute Myocardial Infarction: Insights From the AEGIS-II Trial.

Background: Following an acute myocardial infarction (AMI), patients remain at risk for subsequent cardiovascular (CV) events. In the AEGIS-II trial, CSL112, a human apolipoprotein A-I derived from plasma that enhances cholesterol efflux, did not significantly reduce the first occurrence of CV death, myocardial infarction (MI), or stroke through 90 days compared with placebo. However, an analysis involving only the first event may not capture the totality of the clinical impact of an intervention because patients may experience multiple events.

Apolipoprotein A-I infusions and cardiovascular outcomes in acute myocardial infarction according to baseline LDL-cholesterol levels: the AEGIS-II trial.

Background And Aims: In the AEGIS-II trial (NCT03473223), CSL112, a human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity, did not significantly reduce the risk of the primary endpoint through 90 days vs. placebo after acute myocardial infarction (MI). Nevertheless, given the well-established relationship between higher low-density lipoprotein cholesterol (LDL-C) and plaque burden, as well as greater risk reductions seen with PCSK9 inhibitors in patients with baseline LDL-C ≥ 100 mg/dL on statin therapy, the efficacy of CSL112 may be influenced by baseline LDL-C.

Is There an Ideal Diet? Some Insights from the POUNDS Lost Study.

Diets for weight loss have a long history but an ideal one has not yet been clearly identified. To compare low-fat and lower carbohydrate diets, we designed The Preventing Overweight by Novel Dietary Strategies (POUNDS) Lost study. This is a 2 × 2 factorial study with diets of 20% or 40% fat and 15% or 25% protein with a graded carbohydrate intake of 35, 45, 55 and 65%.

Isocaloric replacement of ultraprocessed foods was associated with greater weight loss in the POUNDS Lost trial.

Objective: Higher intake of ultraprocessed foods (UPFs) is associated with obesity. We examined whether replacing UPFs (NOVA 4) with minimally processed foods and culinary ingredients (NOVA 1 + 2) was associated with differential weight change in this secondary prospective analysis of the Preventing Overweight Using Novel Dietary Strategies (POUNDS) Lost trial.

Methods: We estimated percent energy intake (%kcal) from the four NOVA groups using 24-h dietary recalls in a subset of 356 participants.