Mediterranean Diet and the Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT00640783|
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : March 21, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Mediterranean diet Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of a Mediterranean-Style Diet on Endothelial Dysfunction and Markers of Vascular Inflammation in the Metabolic Syndrome|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||October 2003|
|Actual Study Completion Date :||January 2004|
Behavioral: Mediterranean diet
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.
Active Comparator: 2
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%).
- Endothelial function and vascular inflammatory markers [ Time Frame: 2 years ]
- Resolution of metabolic syndrome [ Time Frame: 2 years ]
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): NCT00640783
|Department of Geriatrics and Metabolic Diseases|
|Naples, Italy, 80138|
|Principal Investigator:||Dario Giugliano, MD, PhD||Department of Geriatrics and Metabolic Diseases|