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Mediterranean Diet and the Metabolic Syndrome (MedDiet)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Benoit Lamarche, Laval University
ClinicalTrials.gov Identifier:
NCT00988650
First received: September 25, 2009
Last updated: March 4, 2013
Last verified: March 2013

September 25, 2009
March 4, 2013
May 2007
December 2008   (final data collection date for primary outcome measure)
plasma LDL, TG and HDL-C [ Time Frame: Week 5, 10 and 35 (at the end of each weight-maintaining diet) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988650 on ClinicalTrials.gov Archive Site
CRP, and blood pressure, kinetic of lipoproteins [ Time Frame: Week 5, 10 and 35 (at the end of each weight-maintaining diet) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mediterranean Diet and the Metabolic Syndrome
Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
  • Other: isocaloric diet
    Other Name: 3 isocaloric die
  • Other: free living conditions
    Other Name: weight lost free living conditions
  • Active Comparator: North American diet
    Control North American diet for five weeks in isocaloric conditions
    Intervention: Other: isocaloric diet
  • Experimental: Mediterranean diet
    Mediterranean diet for five weeks in isocaloric conditions
    Intervention: Other: isocaloric diet
  • Experimental: weight loss period
    Weight loss period of 20-week (minimum 5% reduction in body weight)
    Intervention: Other: free living conditions
  • Active Comparator: Weight stabilizing mediterranean diet
    Mediterranean diet for five weeks in isocaloric weight stabilizing conditions
    Intervention: Other: isocaloric diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2008
December 2008   (final data collection date for primary outcome measure)

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)
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00988650
INAF-2006-277
No
Benoit Lamarche, Laval University
Laval University
Canadian Institutes of Health Research (CIHR)
Study Director: Benoît Lamarche, PhD Institute of Nutraceutical and Functional Foods (INAF), Laval University
Laval University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP