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Completed

NCT Number: NCT05244707

The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program

Nutrition is capable of altering the cardiovascular health of the general population. However, the ideal food and nutritional interventions for the secondary prevention of cardiovascular brain disease and for cardiac rehabilitation are still far from being defined, given the lack of scientific evidence in this specific population of individuals with atherosclerotic disease. This work aims to demonstrate that an intensive program will improve cardiovascular risk predictor parameters, such as high systolic blood pressure, altered lipid and glucose profile, used in the SMART Risk Score tool. In this 12-week clinical study with two arms running in parallel, individuals referred to a cardiac rehabilitation program will receive either an intensive food and nutrition intervention program with nutrition consultations, in which the adoption of the Mediterranean diet is promoted, with contacts telephone calls, short text messages, consultation support tools, podcasts, free access short videos, culinary medicine sessions and nutrition "workshops", or the standard of care program recommended in the Nutritional Support Protocol of the Cardiac Rehabilitation Program. At the beginning of the study, at 4 weeks, at 8 weeks and at 12 weeks, blood and urine samples will be collected, body composition, blood pressure, adherence to the Mediterranean dietary pattern will be assessed, by applying the PREDIMED questionnaire and the dietary intake of 24h previous. The quality of life of individuals will be assessed by the EQ-5D-5L questionnaire at the beginning and at the end of the study. It is expected that the increased intensity and support from the intensive program will have a significant impact on the various metabolic and inflammatory markers predictive of cardiovascular risk and that these observed changes will result in a decreased 10-year risk of developing acute myocardial infarction, stroke or vascular death. On the other hand, the intervention is intended to improve quality of life, improve weight control and assess the impact it has on adherence to the Mediterranean dietary pattern.

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Key information

Conditions

Acute Myocardial Infarction With ST Elevation Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NOVA Medical School | Universidade NOVA de Lisboa Campo Mártires da Pátria, 130

Lisbon, 1169-056 Lisboa, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women with ST-segment elevation acute myocardial infarction undergoing primary angioplasty;
  • Ages 30-90 years;
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Subjects with heart failure (LVEF <40%) on admission;
  • Subjects with renal failure (GFR <50 ml / min / 1.73m²);
  • Subjects requiring internment;
  • Subjects who present any other condition that may interfere with adherence to the study protocol.
  • Subjects who attract to be accompanied by another nutritionist;
  • Subjects who have a specific dietary pattern or who take vitamin and/or mineral supplements;
  • Subjects unable to give consent.

Treatment and study plan

Mediterranean style diet

Behavioral

The intervention will consist of an intensive food and nutrition intervention program to improve adherence to the Mediterranean dietary pattern. In addition to individual and face-to-face nutrition consultations, other strategies will be used, such as telephone contacts, short text messages, consultation support tools, podcasts, short open access videos, nutrition workshops and nutrition sessions for caregivers of participants in the study.

Standard of Care

Behavioral

The usual care group will only have access to face-to-face and individual nutrition consultations in order to improve adherence to the Mediterranean dietary pattern.

Primary outcomes

  1. Change in SMART Risk Score

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the change in SMART Risk Score from baseline to the end of follow-up.

Secondary outcomes

  1. Self-reported quality of life

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the EQ-5D-5L questionnaire from baseline to the end of follow-up.

  2. Adherence to the Mediterranean dietary pattern

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in MEDAS questionnaire from baseline to 4 weeks, 8 weeks and 12 weeks.

  3. Change in weight

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the change of weight (kg) from baseline to 12 weeks.

  4. Change in body fat

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the change of body fat (%) from baseline to 12 weeks.

  5. Change in fat free mass

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the change of fat free mass (kg) from baseline to 12 weeks.

  6. Change in total body water

    Time frame: baseline to 12 weeks

    Difference between the intervention and control group in the change of total body water (kg) from baseline to 12 weeks.

  7. Change in systolic blood pressure

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of systolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.

  8. Change in diastolic blood pressure

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of diastolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.

  9. Change of insulin

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of insulin from baseline to 4 weeks, 8 weeks and 12 weeks.

  10. Change of fasting blood glucose

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of fasting blood glucose from baseline to 4 weeks, 8 weeks and 12 weeks.

  11. Change of glycosylated hemoglobin (HbA1c)

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of glycosylated hemoglobin (HbA1c) from baseline to 4 weeks, 8 weeks and 12 weeks.

  12. Change of type 1 insulin-like growth factor (IGF-1)

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of type 1 insulin-like growth factor (IGF-1) from baseline to 4 weeks, 8 weeks and 12 weeks.

  13. Change of LDL cholesterol

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of LDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.

  14. Change of HDL cholesterol

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of HDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.

  15. Change of triglycerides

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of triglycerides from baseline to 4 weeks, 8 weeks and 12 weeks.

  16. Change of apolipoprotein B

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of apolipoprotein B from baseline to 4 weeks, 8 weeks and 12 weeks.

  17. Change of apolipoprotein A1

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of apolipoprotein A1 from baseline to 4 weeks, 8 weeks and 12 weeks.

  18. Change of liporprotein(a)

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of liporprotein(a) from baseline to 4 weeks, 8 weeks and 12 weeks.

  19. Change of high sensitivity C-reactive protein

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of high sensitivity C-reactive protein from baseline to 4 weeks, 8 weeks and 12 weeks.

  20. change of myeloperoxidase

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of myeloperoxidase from baseline to 4 weeks, 8 weeks and 12 weeks.

  21. Change of interleukin 1

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of interleukin 1 from baseline to 4 weeks, 8 weeks and 12 weeks.

  22. Change of interleukin 6

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of interleukin 6 from baseline to 4 weeks, 8 weeks and 12 weeks.

  23. Change of tumor necrosis factor alpha (TNF-α)

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of tumor necrosis factor alpha (TNF-α) from baseline to 4 weeks, 8 weeks and 12 weeks.

  24. Change of trimethylamine N-oxide (TMAO)

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of trimethylamine N-oxide (TMAO) from baseline to 4 weeks, 8 weeks and 12 weeks.

  25. Change of L-carnitine

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of L-carnitine from baseline to 4 weeks, 8 weeks and 12 weeks.

  26. Change of urinary hydroxytyrosol

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of urinary hydroxytyrosol from baseline to 4 weeks, 8 weeks and 12 weeks.

  27. Change of plasma proportion of alpha linolenic acid

    Time frame: baseline, 4 weeks, 8 weeks and 12 weeks

    Difference between the intervention and control group in the change of plasma proportion of alpha linolenic acid from baseline to 4 weeks, 8 weeks and 12 weeks.

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Centro Hospitalar de Lisboa Central

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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