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

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: Completed
• Conditions: Myocardial Infarction First
• Intervention / Treatment: Other: Plant based diet; Other: Diet based on the recommendations of the European Society of Cardiology

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: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Masaryk university

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of participants enrolled in the study	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	Percentage of the enrolled patients completed the study.	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight after diet changes	Change from baseline InBody - bioelectrical impedance analysis Unit: kg	3 months
Changes in viceral fat area after diet changes	Change from baseline. InBody - bioelectrical impedance analysis Unit: cm3	3 month
Changes in skeletal muscle mass after diet changes	Change from baseline InBody - bioelectrical impedance analysis Unit: kg	3 month
Changes in body fat mass after diet changes	Change in baseline InBody - bioelectrical impedance analysis Unit: kg	3 month
Changes in total body water after diet changes	Change from baseline InBody - bioelectrical impedance analysis Unit: litr	3 month
Changes in body mass index after diet changes	Change from baseline InBody - bioelectrical impedance analysis Unit: kg/m2	3 month
Changes in glycated hemoglobin after diet changes	Change from baseline Blood test Unit: mmol/mol	3 month
Changes in potassium after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in magnesium after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in iron after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in fasting glucose after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in total cholesterol after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in LDL-cholesterol after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in HDL-cholesterol after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in triglycerides after diet changes	Change from baseline Blood test Unit: mmol/l	3 month
Changes in lipoprotein(a) after diet changes	Change from baseline Blood test Unit: nmol/l	3 month
Changes in IL-6 after diet changes	Change from baseline Blood test Unit: ng/l	3 month
Changes in hsCRP after diet changes	Change from baseline Blood test Unit: mg/l	3 month
Changes in vitamin B12 after diet changes	Change from baseline Blood test Unit: pmol/l	3 month
Changes in 25-hydroxyvitamin D after diet changes	Change from baseline Blood test Unit: nmol/l	3 month
Changes in ferritin after diet changes	Change from baseline Blood test Unit: ug/l	3 month
Changes in transferin after diet changes	Change from baseline Blood test Unit: g/l	3 month
Changes in hemoglobin after diet changes	Change from baseline Blood test Unit: g/l	3 month
Changes in body fat after diet changes	Change from baseline InBody - bioelectrical impedance analysis Unit: %	3 month
Changes in calcium after diet changes	Change from baseline Blood test Unit: mmol/l	3 month

Collaborators and Investigators

• Sponsor: Radana Dymáčková
• Collaborators: Masaryk University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Myocardial Infarction; Plant based diet; Diet recommended European Society of Cardiology
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Plant-Based
• Other Study ID 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