NCT06353009

Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Matthieu Pelletier-Galarneau, MD MSc · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Myocardial Endothelial Function

Interventions

Type	Name	Description
OTHER	NOVA4 meal	NOVA (a name, not an acronym) is a food classification system divided into four groups, based on the level of processing. Group 4 - Ultra-processed foods. They are the ones that use many ingredients including food additives that improve palatability, processed raw materials (hydrogenated fats, modified starches, etc.) and ingredients that are rarely used in home cooking such as soy protein or mechanically separated meat. These foods are mainly of industrial origin and are characterized by a good pleasantness and the fact that they can be stored for a long time.
OTHER	NOVA1-3 meal	NOVA (a name, not an acronym) is a food classification system divided into four groups, based on the level of processing. Group 1 - Unprocessed or minimally processed foods (fruit, vegetables, eggs, meat, milk, etc.) Group 2 - Foods processed in the kitchen with the aim of extending their shelf life. In practice, these are ingredients to be used in the kitchen such as fats, aromatic herbs, etc. to be kept in jars or in the refrigerator to be able to use them later. Group 3 - Processed foods. These are the foods obtained by combining foods of groups 1 and 2 to obtain the many food products for domestic use (bread, jams, etc.) made up of a few ingredients

Timeline

• Start date: 2020-08-20
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

1 site across 1 country: Canada