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NCT Number: NCT07576400

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

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.

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Key information

Conditions

Myocardial Infarction First Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masaryk university

Brno, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myocardial Infarction First

Exclusion criteria

  • Myocardial Infarction Second
  • Age under 18

Treatment and study plan

Plant based diet

Other

Change dietary habits for tree months

Diet based on the recommendations of the European Society of Cardiology

Other

Change dietary habits for tree months

Primary outcomes

  1. 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.

  2. Percentage of participants completed the study

    Time frame: 3 month

    Percentage of the enrolled patients completed the study.

Secondary outcomes

  1. Changes in weight after diet changes

    Time frame: 3 months

    Change from baseline InBody - bioelectrical impedance analysis Unit: kg

  2. Changes in viceral fat area after diet changes

    Time frame: 3 month

    Change from baseline. InBody - bioelectrical impedance analysis Unit: cm3

  3. Changes in skeletal muscle mass after diet changes

    Time frame: 3 month

    Change from baseline InBody - bioelectrical impedance analysis Unit: kg

  4. Changes in body fat mass after diet changes

    Time frame: 3 month

    Change in baseline InBody - bioelectrical impedance analysis Unit: kg

  5. Changes in total body water after diet changes

    Time frame: 3 month

    Change from baseline InBody - bioelectrical impedance analysis Unit: litr

  6. Changes in body mass index after diet changes

    Time frame: 3 month

    Change from baseline InBody - bioelectrical impedance analysis Unit: kg/m2

  7. Changes in glycated hemoglobin after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/mol

  8. Changes in potassium after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  9. Changes in magnesium after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  10. Changes in iron after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  11. Changes in fasting glucose after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  12. Changes in total cholesterol after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  13. Changes in LDL-cholesterol after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  14. Changes in HDL-cholesterol after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  15. Changes in triglycerides after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

  16. Changes in lipoprotein(a) after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: nmol/l

  17. Changes in IL-6 after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: ng/l

  18. Changes in hsCRP after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mg/l

  19. Changes in vitamin B12 after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: pmol/l

  20. Changes in 25-hydroxyvitamin D after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: nmol/l

  21. Changes in ferritin after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: ug/l

  22. Changes in transferin after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: g/l

  23. Changes in hemoglobin after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: g/l

  24. Changes in body fat after diet changes

    Time frame: 3 month

    Change from baseline InBody - bioelectrical impedance analysis Unit: %

  25. Changes in calcium after diet changes

    Time frame: 3 month

    Change from baseline Blood test Unit: mmol/l

Sponsors and collaborators

Lead sponsor

Radana Dymáčková

Other

Collaborators

  • Masaryk University

Registry information

Official study title

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

Acronym: PBN in IM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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