Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

University of Palermo

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Behavioral: mediterranean diet; Behavioral: low fat

Study type: Interventional

Funder types: Other

Identifiers

NCT04873167

U Palermo

Details and patient eligibility

About

Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes

Full description

The investigators have designed a study project to evaluate in a sample of patients with high cardiovascular risk:

1. The effects of adherence to Mediterranean Diet on serum levels of some metabolic variables (glucose blood levels, serum LDL cholesterol, serum total cholesterol, serum triglycerides)

2. The effects of adherence to Mediterranean Diet on serum levels of some ceramides and of adiponectin and resistin at 6 and 12-month follow-up

3. The effects of adherence to a Mediterranean Diet style on some surrogate markers of vascular damage such ad endothelial function measured by means of the evaluation of reactive hyperemia index (RHI) and arterial stiffness markers (PWV, AIX) at 6 and 12-month follow-ups

4. The effects of adherence to Mediterranean Diet on the genetic expression of some cardiometabolic and atherothrombotic candidate genes at 12-month follow-up

5. The effects of the Mediterranean diet adherence on the incidence of cardio and cerebrovascular events at 12 and 18 month follow-ups considering respectively:

   1. composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes
   2. secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes

Enrollment: 155 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least two of the following eligibility criteria:

  1. Type 2 diabetes mellitus
  2. Arterial hypertension
  3. BMI ≥ 25
  4. Active smoking
  5. Family history of early cardiovascular disease
  6. Previous cardiovascular or cerebrovascular events (> 6 months)

Exclusion criteria

• All patients with recent (<6 months) cardiovascular or cerebrovascular events were excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

Low Fat Diet

Experimental group

Description:

subjects subjected to a low-fat dietary regime

Treatment:

Behavioral: low fat

Mediterranean Diet

Experimental group

Description:

subjects subjected to a mediterranean dietary regime

Treatment:

Behavioral: mediterranean diet