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Mediterranean Diet and the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mediterranean diet
Control
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Mediterranean diet, Inflammatory markers, Endothelial function

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be enrolled in the study, patients had to have 3 or more of the following criteria to meet the diagnosis of the metabolic syndrome, as defined by the Adult Treatment Panel III

Exclusion Criteria:

  • Patients were excluded if they had cardiovascular disease, psychiatric problems, a history of alcohol abuse (alcohol consumption 500 g/wk in the last year), if they smoked, or if they took any medication.

Sites / Locations

  • Department of Geriatrics and Metabolic Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Mediterranean diet

Control diet

Outcomes

Primary Outcome Measures

Endothelial function and vascular inflammatory markers

Secondary Outcome Measures

Resolution of metabolic syndrome

Full Information

First Posted
March 4, 2008
Last Updated
March 19, 2008
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00640783
Brief Title
Mediterranean Diet and the Metabolic Syndrome
Official Title
Effect of a Mediterranean-Style Diet on Endothelial Dysfunction and Markers of Vascular Inflammation in the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The metabolic syndrome has been identified as a target for dietary therapies to reduce risk of cardiovascular disease; however, the role of diet in the etiology of the metabolic syndrome is poorly understood. To assess the effect of a Mediterranean-style diet on endothelial function and vascular inflammatory markers in patients with the metabolic syndrome Randomized, single-blind trial conducted from June 2001 to January 2004 at a university hospital in Italy among 180 patients (99 men and 81 women) with the metabolic syndrome, as defined by the Adult Treatment Panel III. Patients in the intervention group (n = 90) were instructed to follow a Mediterranean-style diet and received detailed advice about how to increase daily consumption of whole grains, fruits, vegetables, nuts, and olive oil; patients in the control group (n = 90) followed a prudent diet (carbohydrates, 50%-60%; proteins, 15%-20%; total fat, <30%). After 2 years, patients following the Mediterranean-style diet consumed more foods rich in monounsaturated fat, polyunsaturated fat, and fiber and had a lower ratio of omega-6 to omega-3 fatty acids. Total fruit, vegetable, and nuts intake (274 g/d), whole grain intake (103 g/d), and olive oil consumption (8 g/d) were also significantly higher in the intervention group (P<.001). The level of physical activity increased in both groups by approximately 60%, without difference between groups. Mean body weight decreased more in patients in the intervention group (-4.0 kg) than in those in the control group (-1.2 kg) (P<.001). Compared with patients consuming the control diet, patients consuming the intervention diet had significantly reduced serum concentrations of hs-CRP (P = .01), IL-6 (P = .04), IL-7 (P = 0.4), and IL-18 (P = 0.3), as well as decreased insulin resistance (P<.001). Endothelial function score improved in the intervention group but remained stable in the control group. At 2 years of follow-up, 40 patients in the intervention group still had features of the metabolic syndrome, compared with 78 patients in the control group (P<.001). A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic syndrome and its associated cardiovascular risk.
Detailed Description
Patients consuming the intervention diet were given detailed advice about the usefulness of the experimental diet. Through a series of monthly small-group sessions, intervention patients received education in reducing dietary calories (if needed), personal goal-setting, and self-monitoring using food diaries. Behavioral and psychological counseling was also offered. The dietary advice was tailored to each patient on the basis of 3-day food records. The recommended composition of the dietary regimen was as follows: carbohydrates, 50% to 60%; proteins, 15% to 20%; total fat, less than 30%; saturated fat, less than 10%; and cholesterol consumption, less than 300 mg per day. Moreover, patients were advised to consume at least 250 to 300 g of fruits, 125 to 150 g of vegetables, and 25 to 50 g of walnuts per day; in addition, they were also encouraged to consume 400 g of whole grains (legumes, rice, maize, and wheat) daily and to increase their consumption of olive oil. Patients were in the program for 24 months and had monthly sessions with the nutritionist for the first year and bimonthly sessions for the second year. Compliance with the program was assessed by attendance at the meetings and completion of the diet diaries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Mediterranean diet, Inflammatory markers, Endothelial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Mediterranean diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control diet
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet
Intervention Description
The dietary advice was tailored to each patient on the basis of 3-day food records. The recommended composition of the dietary regimen was as follows: carbohydrates, 50% to 60%; proteins, 15% to 20%; total fat, less than 30%; saturated fat, less than 10%; and cholesterol consumption, less than 300 mg per day. Moreover, patients were advised to consume at least 250 to 300 g of fruits, 125 to 150 g of vegetables, and 25 to 50 g of walnuts per day; in addition, they were also encouraged to consume 400 g of whole grains (legumes, rice, maize, and wheat) daily and to increase their consumption of olive oil.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Patients consuming the control diet were given general oral and written information about healthy food choices at baseline and at subsequent visits but were offered no specific individualized program. However, the general recommendation for macronutrient composition of the diet was similar to that for the intervention group (carbohydrates, 50%-60%; proteins, 15%-20%; and total fat, <30%).
Primary Outcome Measure Information:
Title
Endothelial function and vascular inflammatory markers
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Resolution of metabolic syndrome
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be enrolled in the study, patients had to have 3 or more of the following criteria to meet the diagnosis of the metabolic syndrome, as defined by the Adult Treatment Panel III Exclusion Criteria: Patients were excluded if they had cardiovascular disease, psychiatric problems, a history of alcohol abuse (alcohol consumption 500 g/wk in the last year), if they smoked, or if they took any medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD, PhD
Organizational Affiliation
Department of Geriatrics and Metabolic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics and Metabolic Diseases
City
Naples
ZIP/Postal Code
80138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15383514
Citation
Esposito K, Marfella R, Ciotola M, Di Palo C, Giugliano F, Giugliano G, D'Armiento M, D'Andrea F, Giugliano D. Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004 Sep 22;292(12):1440-6. doi: 10.1001/jama.292.12.1440.
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Mediterranean Diet and the Metabolic Syndrome

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