- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640783
Mediterranean Diet and the Metabolic Syndrome
Effect of a Mediterranean-Style Diet on Endothelial Dysfunction and Markers of Vascular Inflammation in the Metabolic Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Naples, Italy, 80138
- Department of Geriatrics and Metabolic Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
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
Control diet
|
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%).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial function and vascular inflammatory markers
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of metabolic syndrome
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dario Giugliano, MD, PhD, Department of Geriatrics and Metabolic Diseases
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGMM/06/2000
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.
Clinical Trials on Metabolic Syndrome
-
Universidad de los Andes, ChileCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
Mayo ClinicCompleted
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on Mediterranean diet
-
Purdue UniversityMushroom CouncilCompleted
-
University of East AngliaNewcastle UniversityRecruitingDepression, AnxietyUnited Kingdom
-
University of California, IrvineCompletedPolycythemia Vera | Essential Thrombocythemia | Myelofibrosis | Myeloproliferative Disorder | Myeloproliferative SyndromeUnited States
-
Gangnam Severance HospitalUnknown
-
Federico II UniversityCompletedMediterranean Diet | Neuroendocrine Tumours (NETs)Italy
-
Azienda Ospedaliera Specializzata in Gastroenterologia...Completed
-
University of California, DavisCompletedInflammation | Diet Modification | HDLUnited States
-
michal rollUnknown
-
University of Campania "Luigi Vanvitelli"CompletedType 2 Diabetes MellitusItaly
-
Chih-Ping ChungNational Yang Ming Chiao Tung UniversityRecruiting