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Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04873167
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Antonino Tuttolomondo, University of Palermo

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

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Behavioral: low fat Behavioral: mediterranean diet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Fat Diet
subjects subjected to a low-fat dietary regime
 Behavioral: low fat
subjects subjected to a low-fat dietary regime
Experimental: Mediterranean Diet
subjects subjected to a mediterranean dietary regime
 Behavioral: mediterranean diet
subjects subjected to a mediterranean dietary regime


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873167


Locations
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Italy
University of Palermo
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
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Principal Investigator: Antonino tuttolomondo University of Palermo
More Information
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Responsible Party: Antonino Tuttolomondo, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT04873167    
Other Study ID Numbers: U Palermo
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No