Dietary Interventions in the Secondary Prevention of Myocardial Infarction: Focus on Plant-Based Nutrition (PBN in IM)

May 4, 2026 updated by: Radana Dymáčková

The Role of Diet in the Secondary Prevention of Myocardial Infarction, With a Focus on a Plant-Based Diet

The goal of this clinical trial is to evaluate whether short-term dietary interventions can improve cardiometabolic risk factors in patients after myocardial infarction. The study includes adult patients following myocardial infarction.

The main questions it aims to answer are:

  • Does adherence to an ESC-recommended diet lead to improvements in lipid profile and body composition compared with no dietary intervention?
  • Does a plant-based (vegan) diet lead to similar or greater improvements in cardiometabolic parameters compared with the control group? Researchers will compare the ESC diet group and the plant-based diet group with a control group to assess their effects on body mass index, lipid profile, and inflammatory markers.

Participants will:

  • be assigned to one of three groups (ESC diet, plant-based diet, or control),
  • receive dietary counselling according to their assigned group (intervention groups),
  • follow the assigned dietary pattern for 3 months,
  • undergo baseline and follow-up clinical and laboratory assessments, including anthropometric measurements and blood sampling.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a single-center, three-arm, controlled, partially randomized interventional pilot study designed to evaluate the feasibility and potential effects of dietary modification in the secondary prevention of myocardial infarction over a three-month period. Participants were recruited between January 2022 and December 2025. The study duration was three months.

Participants who agreed to change their dietary habits were randomized in a 1:1 ratio into two intervention groups using stratified block randomization according to diabetes mellitus status and smoking status. Group A followed a diet based on the recommendations of the European Society of Cardiology (ESC), while Group B adopted a strictly plant-based (vegan) diet.

Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group (Group C), based on patient preference.

All participants underwent clinical and laboratory assessments at baseline and at three months, including body composition analysis using bioimpedance (InBody). In the intervention groups, additional scheduled visits were conducted at monthly intervals during the three-month period. At these visits, participants received nutritional counseling from a registered dietitian and completed a three-day dietary record to assess dietary intake and adherence. Participants were additionally allowed to contact the dietitian or the study physician outside the scheduled visits if needed.

Laboratory analyses included lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, lipoprotein(a), triglycerides), glycemic parameters (fasting blood glucose, glycated hemoglobin HbA1c), inflammatory markers (high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6)), vitamin B12, vitamin D, iron metabolism, complete blood count, and basic biochemical parameters.

Patient recruitment was conducted in collaboration with the coronary care unit of St. Anne's University Hospital Brno (FNUSA). Nutritional counselling was delivered by trained Master's degree nutrition therapy students from the Faculty of Medicine, Masaryk University.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • Masaryk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Myocardial Infarction First

Exclusion Criteria:

  • Myocardial Infarction Second
  • Age under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plant based diet
The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months.
Other: Plant based diet
Change dietary habits for tree months
Experimental: Diet based on the recommendations of the European Society of Cardiology
The intervention arm, in which participants switch to a diet based on the recommendations of the European Society of Cardiology for three months.
Other: Diet based on the recommendations of the European Society of Cardiology
Change dietary habits for tree months
No Intervention: Control arm
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants enrolled in the study
Time Frame: 48 months
In percentage terms, the number of patients contacted and the proportion of those who were subsequently enrolled.
48 months
Percentage of participants completed the study
Time Frame: 3 month
Percentage of the enrolled patients completed the study.
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in weight after diet changes
Time Frame: 3 months
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
3 months
Changes in viceral fat area after diet changes
Time Frame: 3 month
Change from baseline. InBody - bioelectrical impedance analysis Unit: cm3
3 month
Changes in skeletal muscle mass after diet changes
Time Frame: 3 month
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
3 month
Changes in body fat mass after diet changes
Time Frame: 3 month
Change in baseline InBody - bioelectrical impedance analysis Unit: kg
3 month
Changes in total body water after diet changes
Time Frame: 3 month
Change from baseline InBody - bioelectrical impedance analysis Unit: litr
3 month
Changes in body mass index after diet changes
Time Frame: 3 month
Change from baseline InBody - bioelectrical impedance analysis Unit: kg/m2
3 month
Changes in glycated hemoglobin after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/mol
3 month
Changes in potassium after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in magnesium after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in iron after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in fasting glucose after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in total cholesterol after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in LDL-cholesterol after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in HDL-cholesterol after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in triglycerides after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month
Changes in lipoprotein(a) after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: nmol/l
3 month
Changes in IL-6 after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: ng/l
3 month
Changes in hsCRP after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mg/l
3 month
Changes in vitamin B12 after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: pmol/l
3 month
Changes in 25-hydroxyvitamin D after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: nmol/l
3 month
Changes in ferritin after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: ug/l
3 month
Changes in transferin after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: g/l
3 month
Changes in hemoglobin after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: g/l
3 month
Changes in body fat after diet changes
Time Frame: 3 month
Change from baseline InBody - bioelectrical impedance analysis Unit: %
3 month
Changes in calcium after diet changes
Time Frame: 3 month
Change from baseline Blood test Unit: mmol/l
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radana Dymáčková

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Masaryk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2V/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot academic study; there is no need to share the IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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