Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Behavioral: mediterranean diet; Behavioral: low fat

• Registration Number: NCT04873167
• Lead Sponsor: University of Palermo

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

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet	mediterranean diet	subjects subjected to a mediterranean dietary regime
Low Fat Diet	low fat	subjects subjected to a low-fat dietary regime

Primary Outcome Measures

Name	Time	Method
Effects on metabolic variables	Baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Effects on arterial stiffness indexes	Baseline to 12 months	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
effects on serum resistin serum levels	Baseline to 12 months	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.
effects on serum ceramides.	Baseline to 12 months	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.
effects on adiponectin serum levels	Baseline to 12 months	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.
Effects on cardiovascular events	Baseline to 24 months	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.
Effects on surrogate cardiovascular marker (endothelial dysfunction)	Baseline to 12 months	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
effects on gene expression	Baseline and12 months	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)

Trial Locations

Locations (1)

University of Palermo; 🇮🇹 Palermo, Italy