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CompletedNCT07576400PBN in IMUpdated May 8, 2026

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

An interventional study of Plant based diet and Diet based on the recommendations of the European Society of Cardiology in Myocardial Infarction First, sponsored by Radana Dymáčková. Completed at 1 site in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Radana Dymáčková · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Jan 2022, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Myocardial Infarction First

Keywords

  • Myocardial Infarction
  • Plant based diet
  • Diet recommended European Society of Cardiology
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 24 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

This is the only study on the registry with Radana Dymáčková as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Myocardial Infarction First

Exclusion criteria

Exclusion Criteria:

  • Myocardial Infarction Second
  • Age under 18
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    Control arm

    Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.

Interventions

  • OtherPlant based diet

    Change dietary habits for tree months

  • OtherDiet based on the recommendations of the European Society of Cardiology

    Change dietary habits for tree months

06

What researchers measure

Primary outcomes

  1. Percentage of participants enrolled in the study

    In percentage terms, the number of patients contacted and the proportion of those who were subsequently enrolled.

    Time frame: 48 months

  2. Percentage of participants completed the study

    Percentage of the enrolled patients completed the study.

    Time frame: 3 month

Secondary outcomes

  1. Changes in weight after diet changes

    Change from baseline InBody - bioelectrical impedance analysis Unit: kg

    Time frame: 3 months

  2. Changes in viceral fat area after diet changes

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

    Time frame: 3 month

  3. Changes in skeletal muscle mass after diet changes

    Change from baseline InBody - bioelectrical impedance analysis Unit: kg

    Time frame: 3 month

  4. Changes in body fat mass after diet changes

    Change in baseline InBody - bioelectrical impedance analysis Unit: kg

    Time frame: 3 month

  5. Changes in total body water after diet changes

    Change from baseline InBody - bioelectrical impedance analysis Unit: litr

    Time frame: 3 month

  6. Changes in body mass index after diet changes

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

    Time frame: 3 month

  7. Changes in glycated hemoglobin after diet changes

    Change from baseline Blood test Unit: mmol/mol

    Time frame: 3 month

  8. Changes in potassium after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  9. Changes in magnesium after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  10. Changes in iron after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  11. Changes in fasting glucose after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  12. Changes in total cholesterol after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  13. Changes in LDL-cholesterol after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  14. Changes in HDL-cholesterol after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  15. Changes in triglycerides after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

  16. Changes in lipoprotein(a) after diet changes

    Change from baseline Blood test Unit: nmol/l

    Time frame: 3 month

  17. Changes in IL-6 after diet changes

    Change from baseline Blood test Unit: ng/l

    Time frame: 3 month

  18. Changes in hsCRP after diet changes

    Change from baseline Blood test Unit: mg/l

    Time frame: 3 month

  19. Changes in vitamin B12 after diet changes

    Change from baseline Blood test Unit: pmol/l

    Time frame: 3 month

  20. Changes in 25-hydroxyvitamin D after diet changes

    Change from baseline Blood test Unit: nmol/l

    Time frame: 3 month

  21. Changes in ferritin after diet changes

    Change from baseline Blood test Unit: ug/l

    Time frame: 3 month

  22. Changes in transferin after diet changes

    Change from baseline Blood test Unit: g/l

    Time frame: 3 month

  23. Changes in hemoglobin after diet changes

    Change from baseline Blood test Unit: g/l

    Time frame: 3 month

  24. Changes in body fat after diet changes

    Change from baseline InBody - bioelectrical impedance analysis Unit: %

    Time frame: 3 month

  25. Changes in calcium after diet changes

    Change from baseline Blood test Unit: mmol/l

    Time frame: 3 month

07

Study locations

1 site
  • Masaryk university
    Brno, 62500, Czechia
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07576400
Lead sponsor
Radana Dymáčková
Collaborators
Masaryk University
Responsible party
Radana Dymáčková (Msc. Dagmar Struncova, St. Anne's University Hospital Brno, Czech Republic) — Sponsor-investigator
First posted
May 8, 2026
Start date
Jan 20, 2022
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
May 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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