Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
155
subjects subjected to a low-fat dietary regime
subjects subjected to a mediterranean dietary regime
University of Palermo
Palermo, Italy
Effects on metabolic variables
Effects of adherence to Mediterranean Diet in determining a change in serum levels of some metabolic variables (glucose blood levels in mg/dl, serum LDL cholesterol in mg/dl, serum Total cholesterol in mg/dl, serum triglycerides in mg/dl) from baseline to 12 months.
Time frame: Baseline to 12 months
effects on serum resistin serum levels
Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of resistin in ng/ml to 6 and 12 month follow-ups.
Time frame: Baseline to 12 months
effects on serum ceramides.
Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of some ceramides in ug/ml to 6 and 12 month follow-ups.
Time frame: Baseline to 12 months
effects on adiponectin serum levels
Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of adiponectin in mcg/ml to 6 and 12 month follow-ups.
Time frame: Baseline to 12 months
Effects on surrogate cardiovascular marker (endothelial dysfunction)
Effects of adherence to a Mediterranean Diet style in determining a change from baseline values of some surrogate markers of vascular damage such as endothelial function measured by means the evaluation of RHI (reactive hyperemia index) to 6 and 12 month follow-ups
Time frame: Baseline to 12 months
Effects on arterial stiffness indexes
Effects of adherence to a Mediterranean Diet style in determining a change from baseline values of some surrogate markers of vascular damage such as arterial stiffness markers (PWV in m/s, AIX in 100 × ((P2-P1)/(Pulse Pressure) to 6 and 12 month follow-ups
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Time frame: Baseline to 12 months
effects on gene expression
Effects of adherence to Mediterranean Diet in determining a change in the genetic expression of some cardiometabolic and atherothrombotic candidate genes (- C\_29347861\_10, rs7903146, SNP (single nucleotide polymorphism) of TCF7L2 (Transcription Factor 7 Like 2) * C\_32667060\_10, rs17782313, by MC4R ( melanocortin receptor 4) * C\_30090620\_10, rs9939609, SNP of FTO (Fat mass and obesity-associated protein) * C\_29347861\_10, rs7903146, SNP of TCF7L2 * C\_9639448\_10, rs13702, SNP of LPL (lipoprotein lipase) ) at 12 month follow-up with Real-Time PCR (polymerase chain reaction assay)
Time frame: Baseline and12 months
Effects on cardiovascular events
Effects of the Mediterranean diet adherence on the incidence of new cardio and cerebrovascular events at 12 and 24 months follow ups considering a composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes.
Time frame: Baseline to 24 months