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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Fat Diet | Experimental | subjects subjected to a low-fat dietary regime |
|
| Mediterranean Diet | Experimental | subjects subjected to a mediterranean dietary regime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low fat | Behavioral | subjects subjected to a low-fat dietary regime |
| |
| 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 |
| 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. |
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Inclusion Criteria:
at least two of the following eligibility criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonino tuttolomondo | University of Palermo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Palermo | Palermo | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38809909 | Derived | Daidone M, Casuccio A, Puleo MG, Del Cuore A, Pacinella G, Di Chiara T, Di Raimondo D, Immordino P, Tuttolomondo A. Mediterranean diet effects on vascular health and serum levels of adipokines and ceramides. PLoS One. 2024 May 29;19(5):e0300844. doi: 10.1371/journal.pone.0300844. eCollection 2024. |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| mediterranean diet |
| Behavioral |
subjects subjected to a mediterranean dietary regime |
|
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)
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000095500 | Diet, Plant-Based |