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

Not Applicable

• Conditions: Acute Myocardial Infarction With ST Elevation
• Interventions: Behavioral: Mediterranean style diet; Behavioral: Standard of care

• Registration Number: NCT05244707
• Lead Sponsor: Universidade Nova de Lisboa

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17
• Study Start: 2022-03
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean style diet	Mediterranean style diet	Mediterranean style diet.
Standard of care	Standard of care	Standard of care.

Primary Outcome Measures

Name	Time	Method
Change in SMART Risk Score	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.

Secondary Outcome Measures

Name	Time	Method
Change in total body water	baseline to 12 weeks	Difference between the intervention and control group in the change of total body water (kg) from baseline to 12 weeks.
Change of type 1 insulin-like growth factor (IGF-1)	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.
Change of triglycerides	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.
Change of apolipoprotein A1	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.
Adherence to the Mediterranean dietary pattern	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.
Change in fat free mass	baseline to 12 weeks	Difference between the intervention and control group in the change of fat free mass (kg) from baseline to 12 weeks.
Self-reported quality of life	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.
Change of insulin	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.
Change in weight	baseline to 12 weeks	Difference between the intervention and control group in the change of weight (kg) from baseline to 12 weeks.
Change in body fat	baseline to 12 weeks	Difference between the intervention and control group in the change of body fat (%) from baseline to 12 weeks.
Change in diastolic blood pressure	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.
Change of interleukin 1	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.
Change of trimethylamine N-oxide (TMAO)	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.
Change in systolic blood pressure	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.
Change of fasting blood glucose	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.
Change of glycosylated hemoglobin (HbA1c)	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.
Change of LDL cholesterol	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.
Change of HDL cholesterol	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.
Change of apolipoprotein B	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.
Change of interleukin 6	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.
Change of tumor necrosis factor alpha (TNF-α)	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.
Change of plasma proportion of alpha linolenic acid	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.
Change of liporprotein(a)	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.
change of myeloperoxidase	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.
Change of high sensitivity C-reactive protein	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.
Change of L-carnitine	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.
Change of urinary hydroxytyrosol	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.