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

NCT06353009 | Completed

• 1 other identifier: ICM 2021-2720
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Endothelial Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Myocardial blood flow values (ml/min/g) at rest and myocardial reserve.

  4 hours after meal consumption

• Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine.

  4 hours after meal consumption

Interventions

NOVA4 meal OTHER

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.

NOVA1-3 meal OTHER

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women excluded to avoir hormonal cycle variation in endothelial function.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Presence of cardiovascular disease.
• Active smoking or within the past 12 months.
• Hypertension (BP \> 140/90 mmHg).
• Renal failure (Creatinine clearance \< 90 mL/min).
• Type I or II diabetes.
• Dyslipidemia (LDL ≥ 3.5 mmol/L or total cholesterol/HDL ratio ≥ 5.0).
• Heart failure (Left ventricular ejection fraction \< 50%).
• Congenital heart disease.
• Obesity (BMI \> 35 kg/m2).
• Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
• History of severe allergy or reaction to adenosine or dipyridamole.
• Second-degree type II or third-degree atrioventricular block.
• Bradycardia with resting heart rate \< 40 bpm.
• Chronic alcoholism.
• Substance abuse.

Sponsors & Collaborators

• Matthieu Pelletier-Galarneau, MD MSc: lead

Study Sites (1)

Matthieu Pelletier-Galarneau

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

• Lucinian YA, Gagnon C, Latour E, Hamel V, Iglesies-Grau J, Nigam A, Harel F, Nozza A, Juneau M, Moubarac JC, Bherer L, Pelletier-Galarneau M. Effect of a single ultra processed meal on myocardial endothelial function, adenosine mediated effects and cognitive performances. Sci Rep. 2025 Aug 6;15(1):28671. doi: 10.1038/s41598-025-11734-z.

  PMID: 40764338 DERIVED

Study Officials

• Matthieu Pelletier-Galarneau

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, division of nuclear medicine at Institut de cardiologie de Montreal

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 8, 2024
• Study Start: August 20, 2020
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)