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

NCT05244707 | Completed

• 1 other identifier: NutriReHeart
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in SMART Risk Score

  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 Outcomes (27)

• Self-reported quality of life

  baseline to 12 weeks

• Adherence to the Mediterranean dietary pattern

  baseline, 4 weeks, 8 weeks and 12 weeks

• Change in weight

  baseline to 12 weeks

• Change in body fat

  baseline to 12 weeks

• Change in fat free mass

  baseline to 12 weeks

Study Arms (2)

Mediterranean style diet

EXPERIMENTAL

Mediterranean style diet.

Behavioral: Mediterranean style diet

Standard of care

ACTIVE COMPARATOR

Standard of care.

Behavioral: Standard of care

Interventions

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.

Mediterranean style diet

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.

Standard of care

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Hospital de Santa Marta - Centro Hospitalar Universitário, Lisboa Central (CHULC), Portugal: collaborator

Study Sites (1)

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

Lisbon, 1169-056 Lisboa, Portugal

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pedro Rio, MD

  Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)

  PRINCIPAL INVESTIGATOR

• Conceição Calhau, PhD

  NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)