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Mediterranean Diet and Endothelial Function

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ClinicalTrials.gov Identifier: NCT01797211
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
prof. Marco Matteo Ciccone, University of Bari

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Mediterranean diet Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: diet group A
Mediterranean diet+olive oil
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.

Experimental: Diet Group B
Mediterranean diet+not-fried fish
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.

Experimental: Diet Group C
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.




Primary Outcome Measures :
  1. 3 months outcome (composite outcome) [ Time Frame: 3 months after enrollment ]
    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.


Secondary Outcome Measures :
  1. 18 months follow-up evaluations (composite outcome) [ Time Frame: 18 months after enrollment period ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797211


Locations
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Italy
Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, University of Bari
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Marco M Ciccone, MD University of Bari
Principal Investigator: Giovanni De Pergola, MD University of Bari

Publications of Results:

Other Publications:
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Responsible Party: prof. Marco Matteo Ciccone, Associate Professor, University of Bari
ClinicalTrials.gov Identifier: NCT01797211     History of Changes
Other Study ID Numbers: 01
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by prof. Marco Matteo Ciccone, University of Bari:
Mediterranean diet; FMD; obesity; cardiovascular risk.

Additional relevant MeSH terms:
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Cardiovascular Diseases