Clinical trial NCT05244707: The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
Official title: The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction With ST Elevation
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Hospital de Santa Marta - Centro Hospitalar Universitário, Lisboa Central (CHULC), Portugal
First posted: 2022-02-17
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in SMART Risk Score
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Self-reported quality of life
timeFrame: baseline to 12 weeks
measure: Adherence to the Mediterranean dietary pattern
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in weight
timeFrame: baseline to 12 weeks
measure: Change in body fat
timeFrame: baseline to 12 weeks
measure: Change in fat free mass
timeFrame: baseline to 12 weeks
measure: Change in total body water
timeFrame: baseline to 12 weeks
measure: Change in systolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in diastolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of insulin
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of fasting blood glucose
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of glycosylated hemoglobin (HbA1c)
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of type 1 insulin-like growth factor (IGF-1)
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of LDL cholesterol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of HDL cholesterol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of triglycerides
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of apolipoprotein B
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of apolipoprotein A1
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of liporprotein(a)
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of high sensitivity C-reactive protein
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: change of myeloperoxidase
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of interleukin 1
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of interleukin 6
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of tumor necrosis factor alpha (TNF-α)
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of trimethylamine N-oxide (TMAO)
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of L-carnitine
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of urinary hydroxytyrosol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change of plasma proportion of alpha linolenic acid
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)
name: Pedro Rio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
name: André Moreira-Rosário, PhD
role: STUDY_DIRECTOR
affiliation: NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
name: Júlio C Rocha, PhD
role: STUDY_DIRECTOR
affiliation: NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
name: Diana Teixeira, PhD
role: STUDY_DIRECTOR
References: