Mediterranean Diet and the Metabolic Syndrome

NCT00988650 | Completed

• 1 other identifier: INAF-2006-277
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Metabolic syndrome; Mediterranean diet; Blood lipids; Coronary heart disease; Apolipoprotein

Outcome Measures

Primary Outcomes (1)

• plasma LDL, TG and HDL-C

  Week 5, 10 and 35 (at the end of each weight-maintaining diet)

Secondary Outcomes (1)

• CRP, and blood pressure, kinetic of lipoproteins

  Week 5, 10 and 35 (at the end of each weight-maintaining diet)

Study Arms (4)

North American diet

ACTIVE COMPARATOR

Control North American diet for five weeks in isocaloric conditions

Other: isocaloric diet

Mediterranean diet

EXPERIMENTAL

Mediterranean diet for five weeks in isocaloric conditions

Other: isocaloric diet

weight loss period

EXPERIMENTAL

Weight loss period of 20-week (minimum 5% reduction in body weight)

Other: free living conditions

Weight stabilizing mediterranean diet

ACTIVE COMPARATOR

Mediterranean diet for five weeks in isocaloric weight stabilizing conditions

Other: isocaloric diet

Interventions

isocaloric diet OTHER

Also known as: 3 isocaloric die

Mediterranean diet; North American diet; Weight stabilizing mediterranean diet

free living conditions OTHER

Also known as: weight lost free living conditions

weight loss period

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (4)

• Richard C, Couture P, Desroches S, Nehme B, Bourassa S, Droit A, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on the high-density lipoprotein proteome in men with the metabolic syndrome. J Nutrigenet Nutrigenomics. 2014;7(1):48-60. doi: 10.1159/000363137. Epub 2014 Jul 4.

  PMID: 25011605 DERIVED

• Richard C, Couture P, Desroches S, Lichtenstein AH, Lamarche B. Effect of an isoenergetic traditional Mediterranean diet on apolipoprotein A-I kinetic in men with metabolic syndrome. Nutr J. 2013 Jun 7;12(1):76. doi: 10.1186/1475-2891-12-76.

  PMID: 24499022 DERIVED

• Richard C, Couture P, Ooi EM, Tremblay AJ, Desroches S, Charest A, Lichtenstein AH, Lamarche B. Effect of Mediterranean diet with and without weight loss on apolipoprotein B100 metabolism in men with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2014 Feb;34(2):433-8. doi: 10.1161/ATVBAHA.113.302185. Epub 2013 Nov 21.

  PMID: 24265415 DERIVED

• Richard C, Couture P, Desroches S, Lamarche B. Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome. Obesity (Silver Spring). 2013 Jan;21(1):51-7. doi: 10.1002/oby.20239.

  PMID: 23505168 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome; Coronary Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Benoît Lamarche, PhD

  Institute of Nutraceutical and Functional Foods (INAF), Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: October 2, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CA (1)