Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk
1 other identifier
interventional
155
1 country
1
Brief Summary
Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFirst Submitted
Initial submission to the registry
April 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedMay 5, 2021
April 1, 2021
2.3 years
April 17, 2021
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
effects on serum resistin serum levels
Baseline to 12 months
effects on serum ceramides.
Baseline to 12 months
effects on adiponectin serum levels
Baseline to 12 months
Effects on surrogate cardiovascular marker (endothelial dysfunction)
Baseline to 12 months
Effects on arterial stiffness indexes
Baseline to 12 months
- +2 more secondary outcomes
Study Arms (2)
Low Fat Diet
EXPERIMENTALsubjects subjected to a low-fat dietary regime
Mediterranean Diet
EXPERIMENTALsubjects subjected to a mediterranean dietary regime
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- All patients with recent (\<6 months) cardiovascular or cerebrovascular events were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Palermo
Palermo, 90127, Italy
Related Publications (1)
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.
PMID: 38809909DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonino tuttolomondo
University of Palermo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 17, 2021
First Posted
May 5, 2021
Study Start
September 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 5, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share