- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07576400
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Brno, Tjekkiet, 62500
- Masaryk university
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Myocardial Infarction First
Exclusion Criteria:
- Myocardial Infarction Second
- Age under 18
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Plant based diet
The intervention arm, in which participants switch to a strictly plant-based (vegan) diet for three months.
|
Change dietary habits for tree months
|
|
Eksperimentel: 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.
|
Change dietary habits for tree months
|
|
Ingen indgriben: Control arm
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Hjertesygdomme
- Infarkt
- Nekrose
- Myokardieiskæmi
- Iskæmi
- Patologiske tilstande, tegn og symptomer
- Myokardieinfarkt
- Terapeutik
- Diæt, mad og ernæring
- Fysiologiske fænomener
- Ernæringsfysiologiske fænomener
- Diætterapi
- Ernæringsterapi
- Kost
- Diæt, plantebaseret
Andre undersøgelses-id-numre
- 2V/2021
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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