Clinical Trials Directory

Trials / Completed

CompletedNCT01797211

Mediterranean Diet and Endothelial Function

Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of Bari · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTMediterranean dietPatients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.

Timeline

Start date
2010-06-01
Primary completion
2011-04-01
Completion
2012-05-01
First posted
2013-02-22
Last updated
2013-02-22

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01797211. Inclusion in this directory is not an endorsement.