Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873167
• Other study ID #: U Palermo
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Behavioral:
• low fat
subjects subjected to a low-fat dietary regime
• mediterranean diet
subjects subjected to a mediterranean dietary regime

Locations

Country	Name	City	State
Italy	University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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