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

New University of Lisbon

Status: Unknown

Conditions: Acute Myocardial Infarction With ST Elevation

Treatments: Behavioral: Standard of care; Behavioral: Mediterranean style diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05244707

NutriReHeart

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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 <50% or NT_proBNP> 125 ng / mL) on admission;

• Subjects with renal failure (GFR <50 or 60 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Mediterranean style diet

Experimental group

Description:

Mediterranean style diet.

Treatment:

Behavioral: Mediterranean style diet

Standard of care

Active Comparator group

Description:

Standard of care.

Treatment:

Behavioral: Standard of care