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

4. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tsjekkia
      • Brno, Tsjekkia, 62500
        • Masaryk University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Myocardial Infarction First

Exclusion Criteria:

  • Myocardial Infarction Second
  • Age under 18

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Plant based diet
The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months.
Annen: Plant based diet
Change dietary habits for tree months
Eksperimentell: 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.
Annen: Diet based on the recommendations of the European Society of Cardiology
Change dietary habits for tree months
Ingen inngripen: Control arm
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants enrolled in the study
Tidsramme: 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
Tidsramme: 3 month
Percentage of the enrolled patients completed the study.
3 month

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radana Dymáčková

Samarbeidspartnere

Masaryk University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. januar 2022

Primær fullføring (Faktiske)

1. desember 2025

Studiet fullført (Faktiske)

1. desember 2025

Datoer for studieregistrering

Først innsendt

8. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2V/2021

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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