Myocardial Endothelial Function Clinical Trial
Official title:
Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography
The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET). The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly. This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries.
The proposed study is an open-label, randomized crossover trial. This design will allow participants to serve as their own controls. This is critical as there is some variability in response to vasodilators in the population, and by using this research design, we increase our ability to detect small changes. The study consists of 3 visits: a preliminary visit and two imaging visits. During the preliminary visit, the study will be explained to participants, and consent will be obtained. During the imaging visits, participants will consume a meal, and PET imaging will be completed 4 hours later. Half of the participants will consume the Mediterranean meal during the first visit and the ultra-processed meal during the second visit, and vice versa for the other participants. Randomization will determine the order in which the meals are consumed. ;