NCT04873167

Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk by Means Its Influence on Serum Levels of Ceramides and on Some Atherothrombotic Candidate Gene Expression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	low fat	subjects subjected to a low-fat dietary regime
BEHAVIORAL	mediterranean diet	subjects subjected to a mediterranean dietary regime

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2021-05-05
• Last updated: 2021-05-05

Locations

1 site across 1 country: Italy