Mediterranean Diet and the Metabolic Syndrome

Study Overview
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Brief Summary
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While there is now undisputable evidence relating elevated plasma low-density lipoprotein (LDL) cholesterol levels to an increased risk of coronary heart disease (CHD), it is being increasingly recognized that a significant proportion of CHD events occur in individuals characterized by a cluster of additional metabolic and physiological perturbations now defined as the metabolic syndrome. Epidemiological and clinical evidence have shown us that nutritional factors, often in conjunction with obesity, play a pivotal role in the pathophysiology of the metabolic syndrome. In that regard, accumulating evidence suggest that a Mediterranean-style diet (MedDiet) may beneficially modify several components of the metabolic syndrome including plasma triglycerides (TG) and high-density lipoprotein (HDL) cholesterol levels, insulin resistance, waist circumference and markers of vascular inflammation. However, the physiological mechanisms underlying the cardioprotective effects of the MedDiet on features of the metabolic syndrome and the importance of body weight reduction in maximizing these effects represent key issues that have yet to be investigated. The general objective of the study is to investigate for the first time in a controlled feeding study the mechanisms and factors underlying the impact of the MedDiet, with and without weight loss on the dyslipidemic features of the metabolic syndrome.

Detailed Description
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The study has a duration of 35 weeks for each participant. Subjects will be first assigned to a North American control diet that they will consume for five weeks under isocaloric, weight-maintaining conditions. Participants will then consume the MedDiet for 5 weeks, again under isocaloric, weight-maintaining conditions. All foods will be provided to participants during these consecutive 5-week diets. Participants subsequently will then undergo a 20-week weight loss period in free-living conditions during which they will be given advice on how to create a 500 kcal deficit in their daily energy intake. The last phase of the study consists of a second 5-week MedDiet consumed under feeding, weight stabilizing conditions. Metabolic studies and CHD risk factor assessment will be performed at the end of each experimental diets. Metabolic studies include the measurement of in vivo kinetics of apolipoprotein (apo)B-containing lipoproteins including small dense LDL, apoCIII, HDL (apoAI) and C-reactive protein (CRP) as well as indirect measures of cholesterol absorption and synthesis.

Official Title
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Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: isocaloric diet
* Other: free living conditions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men from the Québec City metropolitan area with the metabolic syndrome based on the NCEP-ATP III definition (3 criteria or more see below): Waist circumference ≥ 102 cm Triglycerides ≥ 1.7 mmol/L HDL-cholesterol <= 1.04 mmol/L Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg Fasting blood glucose ≥ 5.6 mmol/L Stable body weight (+/- 2 kg) for 6 months before the beginning of the study Exclusion Criteria: Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia Subjects taking medications for hyperlipidemia or hypertension Endocrine disorders Food allergies or aversion for specific components of the MedDiet Smokers Consummation excessive of alcohol (> 2 consummation/day)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: North American diet<br>Control North American diet for five weeks in isocaloric conditions | Other: isocaloric diet<br> <br> * Other names: 3 isocaloric die;|
| Experimental: Mediterranean diet<br>Mediterranean diet for five weeks in isocaloric conditions | Other: isocaloric diet<br> <br> * Other names: 3 isocaloric die;|
| Experimental: weight loss period<br>Weight loss period of 20-week (minimum 5% reduction in body weight) | Other: free living conditions<br> <br> * Other names: weight lost free living conditions;|
| Active Comparator: Weight stabilizing mediterranean diet<br>Mediterranean diet for five weeks in isocaloric weight stabilizing conditions | Other: isocaloric diet<br> <br> * Other names: 3 isocaloric die;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma LDL, TG and HDL-C |  | Week 5, 10 and 35 (at the end of each weight-maintaining diet) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP, and blood pressure, kinetic of lipoproteins |  | Week 5, 10 and 35 (at the end of each weight-maintaining diet) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Mediterranean diet, Blood lipids, Coronary heart disease, Apolipoprotein