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

February 12, 2026 updated by: Universidade Nova de Lisboa
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
      • Lisbon, Portugal, 1169-056 Lisboa
        • NOVA Medical School | Universidade NOVA de Lisboa Campo Mártires da Pátria, 130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mediterranean style diet
Mediterranean style diet.
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.
Active Comparator: Standard of care
Standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
baseline to 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline to 12 weeks
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.
baseline to 12 weeks
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.
baseline to 12 weeks
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.
baseline to 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks
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.
baseline, 4 weeks, 8 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Nova de Lisboa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital de Santa Marta - Centro Hospitalar Universitário, Lisboa Central (CHULC), Portugal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pedro Rio, MD, Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)
  • Study Director: André Moreira-Rosário, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
  • Study Director: Júlio C Rocha, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
  • Study Director: Diana Teixeira, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
  • Principal Investigator: Conceição Calhau, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NutriReHeart

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be publicly shared because the ethics committee has limited their use to the approved research project. However, anonymised partial data sets or summary data may be made available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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