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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Endothelial Function
• Intervention / Treatment: Other: NOVA4 meal; Other: NOVA1-3 meal

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Matthieu Pelletier-Galarneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men aged between 18 and 50 years.
2. Absence of cardiovascular symptoms.
3. Ability to provide free and informed consent.

Exclusion Criteria:

1. Presence of cardiovascular disease.
2. Active smoking or within the past 12 months.
3. Hypertension (BP > 140/90 mmHg).
4. Renal failure (Creatinine clearance < 90 mL/min).
5. Type I or II diabetes.
6. Dyslipidemia (LDL ≥ 3.5 mmol/L or total cholesterol/HDL ratio ≥ 5.0).
7. Heart failure (Left ventricular ejection fraction < 50%).
8. Congenital heart disease.
9. Obesity (BMI > 35 kg/m2).
10. Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
11. History of severe allergy or reaction to adenosine or dipyridamole.
12. Second-degree type II or third-degree atrioventricular block.
13. Bradycardia with resting heart rate < 40 bpm.
14. Chronic alcoholism.
15. Substance abuse.
16. Claustrophobia.
17. Vegetarianism.
18. Use of statins or beta-blockers.
19. Food allergy preventing consumption of study meals.
20. Participation in this project would result in cumulative research study radiation dose > 50 mSv in the past 12 months.
21. Neurocognitive disorders or medication use affecting cognition.
22. Any condition that, in the opinion of the investigators, could compromise the subject's participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial blood flow values (ml/min/g) at maximum dose of adenosine.	The difference in maximum dose adenosine myocardial blood flow measured after consumption of ultra-processed (NOVA 4) and Mediterranean meals (NOVA 1-3) in healthy subjects.	4 hours after meal consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial blood flow values (ml/min/g) at rest and myocardial reserve.	The difference in myocardial blood flow at rest and myocardial reserve, measured after ultra-processed (NOVA 4) and Mediterranean (NOVA1-3) meals in healthy subjects.	4 hours after meal consumption
Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine.	The difference in myocardial blood flow at intermediate dose of adenosine, measured after ultra-processed (NOVA 4) and Mediterranean (NOVA 1-3) meals in healthy subjects.	4 hours after meal consumption

Collaborators and Investigators

• Sponsor: Matthieu Pelletier-Galarneau, MD MSc
• Investigators: Principal Investigator: Matthieu Pelletier-Galarneau, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ICM 2021-2720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No