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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Myocardial Infarction With ST Elevation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mediterranean style diet

Mediterranean style diet.

Group Type EXPERIMENTAL

Mediterranean style diet

Intervention Type 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

Standard of care.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No