Myocardial Endothelial FunctionSUPPERNCT06353009
Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography
A study testing NOVA4 meal and NOVA1-3 meal in people with Myocardial Endothelial Function, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myocardial Endothelial Function
- What is being tested?
- NOVA4 meal and NOVA1-3 meal
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2020to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged between 18 and 50 years.
- Absence of cardiovascular symptoms.
- Ability to provide free and informed consent.
Who cannot join
- 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).
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- 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.
- Claustrophobia.
- Vegetarianism.
- Use of statins or beta-blockers.
- Food allergy preventing consumption of study meals.
- Participation in this project would result in cumulative research study radiation dose > 50 mSv in the past 12 months.
- Neurocognitive disorders or medication use affecting cognition.
- Any condition that, in the opinion of the investigators, could compromise the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- NOVA4 meal, NOVA1-3 meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVA4 mealOther
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 mealOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours after meal consumption
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Aug 2020
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Endothelial FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute
- Investigators
- Matthieu Pelletier-Galarneau, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353009
- Sponsor's protocol ID
- ICM 2021-2720
- Acronym
- SUPPER
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40764338
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT06353009
- Acronym / sponsor ID
- SUPPER / ICM 2021-2720
- Conditions
- Myocardial Endothelial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MScUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men aged between 18 and 50 years.
- Absence of cardiovascular symptoms.
- Ability to provide free and informed consent.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVA4 mealNOVA (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 mealNOVA (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 | Other | – |
Primary outcome
Myocardial blood flow values (ml/min/g) at maximum dose of adenosine.
Time frame: 4 hours after meal consumption
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.
2 secondary outcomes
Myocardial blood flow values (ml/min/g) at rest and myocardial reserve.
Time frame: 4 hours after meal consumption
Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine.
Time frame: 4 hours after meal consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40764338Lucinian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Pelletier-Galarneau principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVA4 meal and NOVA1-3 meal in people with Myocardial Endothelial Function, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blood flow values (ml/min/g) at maximum dose of adenosine. (time frame: 4 hours after meal consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06353009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.