NCT07576400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3.9 years

First QC Date

April 8, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Myocardial InfarctionPlant based dietDiet recommended European Society of Cardiology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (25)

  • Changes in weight after diet changes

    3 months

  • Changes in viceral fat area after diet changes

    3 month

  • Changes in skeletal muscle mass after diet changes

    3 month

  • Changes in body fat mass after diet changes

    3 month

  • Changes in total body water after diet changes

    3 month

  • +20 more secondary outcomes

Study Arms (3)

Plant based diet

EXPERIMENTAL

The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months.

Other: Plant based diet

Diet based on the recommendations of the European Society of Cardiology

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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

Interventions

Change dietary habits for tree months

Plant based diet

Change dietary habits for tree months

Diet based on the recommendations of the European Society of Cardiology

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myocardial Infarction First

You may not qualify if:

  • Myocardial Infarction Second
  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk university

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Msc. Dagmar Struncova

Study Record Dates

First Submitted

April 8, 2026

First Posted

May 8, 2026

Study Start

January 20, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations