Mediterranean Diet and Endothelial Function

February 20, 2013 updated by: prof. Marco Matteo Ciccone, University of Bari

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, University of Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months after enrollment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Marco M Ciccone, MD, University of Bari
  • Principal Investigator: Giovanni De Pergola, MD, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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