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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Brno、チェコ、62500
- Masaryk University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Myocardial Infarction First
Exclusion Criteria:
- Myocardial Infarction Second
- Age under 18
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
実験的：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
|
|
介入なし：Control arm
Patients who declined dietary modification but agreed to undergo study assessments were included as a parallel, non-intervention control group.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants enrolled in the study
時間枠：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
時間枠：3 month
|
Percentage of the enrolled patients completed the study.
|
3 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in weight after diet changes
時間枠：3 months
|
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
|
3 months
|
|
Changes in viceral fat area after diet changes
時間枠：3 month
|
Change from baseline.
InBody - bioelectrical impedance analysis Unit: cm3
|
3 month
|
|
Changes in skeletal muscle mass after diet changes
時間枠：3 month
|
Change from baseline InBody - bioelectrical impedance analysis Unit: kg
|
3 month
|
|
Changes in body fat mass after diet changes
時間枠：3 month
|
Change in baseline InBody - bioelectrical impedance analysis Unit: kg
|
3 month
|
|
Changes in total body water after diet changes
時間枠：3 month
|
Change from baseline InBody - bioelectrical impedance analysis Unit: litr
|
3 month
|
|
Changes in body mass index after diet changes
時間枠：3 month
|
Change from baseline InBody - bioelectrical impedance analysis Unit: kg/m2
|
3 month
|
|
Changes in glycated hemoglobin after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/mol
|
3 month
|
|
Changes in potassium after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in magnesium after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in iron after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in fasting glucose after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in total cholesterol after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in LDL-cholesterol after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in HDL-cholesterol after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in triglycerides after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
|
Changes in lipoprotein(a) after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: nmol/l
|
3 month
|
|
Changes in IL-6 after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: ng/l
|
3 month
|
|
Changes in hsCRP after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mg/l
|
3 month
|
|
Changes in vitamin B12 after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: pmol/l
|
3 month
|
|
Changes in 25-hydroxyvitamin D after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: nmol/l
|
3 month
|
|
Changes in ferritin after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: ug/l
|
3 month
|
|
Changes in transferin after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: g/l
|
3 month
|
|
Changes in hemoglobin after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: g/l
|
3 month
|
|
Changes in body fat after diet changes
時間枠：3 month
|
Change from baseline InBody - bioelectrical impedance analysis Unit: %
|
3 month
|
|
Changes in calcium after diet changes
時間枠：3 month
|
Change from baseline Blood test Unit: mmol/l
|
3 month
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2V/2021
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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