A Phase 4 interventional study of Mediterranean diet in Cardiovascular Diseases, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-22.
Sponsored by University of Bari · Phase 4, Interventional, and Prevention
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
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.
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This study's enrollment of 60 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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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.
Mediterranean diet+olive oil
Dietary Supplement: Mediterranean diet
Mediterranean diet+not-fried fish
Dietary Supplement: Mediterranean diet
Mediterranean diet+nuts
Dietary Supplement: Mediterranean diet
Patients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.
3 months outcome (composite outcome)
Anthropometric parameters (BMI, waist circumference \[WC\] and weight) a significant decrease, while FMD ones showed a significant increase after 3 months of Mediterranean diet as compared to baseline levels. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. After 3 months, FMD was not higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet.
Time frame: 3 months after enrollment
18 months follow-up evaluations (composite outcome)
After 18 months of dietary treatment, we observed a significant increase of HDL-C, a decrease of TC and LDL-C, no differences in TG plasma concentrations and fasting glucose. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence the lipid profile. Anthropometric parameters showed a significant decrease and FMD showed a significant increase after 18 months, as compared to 3 months levels. Olive oil, non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. It is noteworthy that, after 18 months of Mediterranean diet, but not after 3 months, FMD was higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet. Lastly, at 18 months, the FMD levels of groups A, B, and C were significantly higher than those of control group.
Time frame: 18 months after enrollment period
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University of Bari