Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

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

Detailed Description
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The investigators have designed a study project to evaluate in a sample of patients with high cardiovascular risk: 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) 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 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 The effects of adherence to Mediterranean Diet on the genetic expression of some cardiometabolic and atherothrombotic candidate genes at 12-month follow-up The effects of the Mediterranean diet adherence on the incidence of cardio and cerebrovascular events at 12 and 18 month follow-ups considering respectively: composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes

Official Title
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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

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: low fat
* Behavioral: mediterranean diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least two of the following eligibility criteria: Type 2 diabetes mellitus Arterial hypertension BMI ≥ 25 Active smoking Family history of early cardiovascular disease Previous cardiovascular or cerebrovascular events (> 6 months) Exclusion Criteria: All patients with recent (<6 months) cardiovascular or cerebrovascular events were excluded.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Fat Diet<br>subjects subjected to a low-fat dietary regime | Behavioral: low fat<br>* subjects subjected to a low-fat dietary regime<br>|
| Experimental: Mediterranean Diet<br>subjects subjected to a mediterranean dietary regime | Behavioral: mediterranean diet<br>* subjects subjected to a mediterranean dietary regime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 | 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) | 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. | Baseline to 24 months |