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

Summary

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.

Conditions

• Acute Myocardial Infarction With ST Elevation

Interventions

BEHAVIORAL

Mediterranean style diet

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.

BEHAVIORAL

Standard of care

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.

Sponsors & Collaborators

• Hospital de Santa Marta - Centro Hospitalar Universitário, Lisboa Central (CHULC), Portugal

  collaborator UNKNOWN

• Universidade Nova de Lisboa

  lead OTHER

Principal Investigators

• Pedro Rio, MD · Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)

• Conceição Calhau, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

• André Moreira-Rosário, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

• Júlio C Rocha, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

• Diana Teixeira, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Portugal

Study Locations