Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353009
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-03-15
Brief Title:
Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography
Sponsor:
Matthieu Pelletier-Galarneau MD MSc
Organization:
Montreal Heart Institute
Study Overview
Official Title:
Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPER
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None