Clinical trial NCT01797211: Mediterranean Diet and Endothelial Function
Official title: Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Keywords: Mediterranean diet; FMD; obesity; cardiovascular risk.
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients

Detailed description: Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction.

Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. Changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. Recent studies seem to show that Mediterranean diet has beneficial role on cardiovascular risk. It could protect against the development of coronary heart disease also through a possible effect on body weight and obesity.

At the best of our knowledge, the effect of Mediterranean diet on endothelial function in obese subjects has not been definitely established. Therefore, the aim of this study was to evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and waist circumference), lipid profile \[total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)\], triglycerides (TG), fasting glucose and endothelium function, evaluated by FMD, in a group of obese and overweight subjects. In particular, subjects were invited to follow a standard Mediterranean diet for a short (3 months) or a longer (18 months) period. The specific role of some components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.

Eligibility criteria: Inclusion Criteria:

BMI: \> 25.0 kg/m2 Age between 18-70 years

Exclusion Criteria:

BMI \< 25.0 kg/m2 Age \<18 or \>70 years low left ventricular ejection fraction (LVEF \< 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.

Primary outcomes:
measure: 3 months outcome (composite outcome)
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: 18 months follow-up evaluations (composite outcome)
timeFrame: 18 months after enrollment period
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, University of Bari
Study officials:
affiliation: University of Bari
name: Marco M Ciccone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bari
name: Giovanni De Pergola, MD
role: PRINCIPAL_INVESTIGATOR
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