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

4 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Chequia
      • Brno, Chequia, 62500
        • Masaryk University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Myocardial Infarction First

Exclusion Criteria:

  • Myocardial Infarction Second
  • Age under 18

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Plant based diet
The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months.
Otro: 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.
Otro: Diet based on the recommendations of the European Society of Cardiology
Change dietary habits for tree months
Sin intervención: Control arm
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of participants enrolled in the study
Periodo de tiempo: 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
Periodo de tiempo: 3 month
Percentage of the enrolled patients completed the study.
3 month

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radana Dymáčková

Colaboradores

Masaryk University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de enero de 2022

Finalización primaria (Actual)

1 de diciembre de 2025

Finalización del estudio (Actual)

1 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

8 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

8 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2V/2021

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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