Cardiovascular Risk FactorNCT04873167
Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk
A study testing low fat and mediterranean diet in people with Cardiovascular Risk Factor, run by University of Palermo at 1 site in Italy.
Trial summary
Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- low fat and mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- All patients with recent (<6 months) cardiovascular or cerebrovascular events were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes
Read the detailed description
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
- Conditions
- Cardiovascular Risk Factor
- Being tested
- low fat, mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fatBehavioural
subjects subjected to a low-fat dietary regime
mediterranean dietBehavioural
subjects subjected to a mediterranean dietary regime
| Study group | Role | What they receive |
|---|---|---|
| Low Fat Diet | Experimental | subjects subjected to a low-fat dietary regime Receives: Behavioral: low fat |
| Mediterranean Diet | Experimental | subjects subjected to a mediterranean dietary regime Receives: Behavioral: mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (7)
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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
Measured: Baseline to 12 months
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
Measured: Baseline to 12 months
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)
Measured: Baseline and12 months
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.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Tuttolomondo, University of Palermo
- Investigators
- Antonino tuttolomondo, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873167
- Sponsor's protocol ID
- U Palermo
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38809909
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04873167
- Acronym / sponsor ID
- U Palermo
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fat Diet | Experimental | Behavioral: low fatsubjects subjected to a low-fat dietary regime |
| Mediterranean Diet | Experimental | Behavioral: mediterranean dietsubjects subjected to a mediterranean dietary regime |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- at least two of the following eligibility criteria:
Key exclusion criteria (1 listed)
- All patients with recent (<6 months) cardiovascular or cerebrovascular events were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low fatsubjects subjected to a low-fat dietary regime | Behavioural | Low Fat Diet |
| mediterranean dietsubjects subjected to a mediterranean dietary regime | Behavioural | Mediterranean Diet |
Primary outcome
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.
7 secondary outcomes
effects on serum resistin serum levels
Time frame: Baseline to 12 months
effects on serum ceramides.
Time frame: Baseline to 12 months
effects on adiponectin serum levels
Time frame: Baseline to 12 months
Effects on surrogate cardiovascular marker (endothelial dysfunction)
Time frame: Baseline to 12 months
Effects on arterial stiffness indexes
Time frame: Baseline to 12 months
effects on gene expression
Time frame: Baseline and12 months
Effects on cardiovascular events
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 38809909Daidone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino tuttolomondo principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low fat and mediterranean diet in people with Cardiovascular Risk Factor, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on metabolic variables (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.