Skip to main content
OpenTrials
Completed

NCT Number: NCT04873167

Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Risk Factor

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, 90127, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low fat

Behavioral

subjects subjected to a low-fat dietary regime

Mediterranean Diet

Behavioral

subjects subjected to a mediterranean dietary regime

Primary outcomes

  1. Effects on metabolic variables

    Time frame: 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 outcomes

  1. effects on serum resistin serum levels

    Time frame: 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.

  2. effects on serum ceramides.

    Time frame: 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.

  3. effects on adiponectin serum levels

    Time frame: 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.

  4. Effects on surrogate cardiovascular marker (endothelial dysfunction)

    Time frame: 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

  5. Effects on arterial stiffness indexes

    Time frame: 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

  6. effects on gene expression

    Time frame: 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)

  7. Effects on cardiovascular events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 5, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.