Clinical trial NCT04873167: Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 155
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Effects on metabolic variables
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: effects on serum resistin serum levels
timeFrame: Baseline to 12 months
measure: effects on serum ceramides.
timeFrame: Baseline to 12 months
measure: effects on adiponectin serum levels
timeFrame: Baseline to 12 months
measure: Effects on surrogate cardiovascular marker (endothelial dysfunction)
timeFrame: Baseline to 12 months
measure: Effects on arterial stiffness indexes
timeFrame: Baseline to 12 months
measure: effects on gene expression
timeFrame: Baseline and12 months
measure: Effects on cardiovascular events
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University of Palermo
Study officials:
affiliation: University of Palermo
name: Antonino tuttolomondo
role: PRINCIPAL_INVESTIGATOR
References: