Mediterranean Diet and the Metabolic Syndrome

Cardiovascular Disease Clinical Trial

— MedDiet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988650
• Other study ID #: INAF-2006-277
• Status: Completed
• Phase: N/A
• First received: September 25, 2009
• Last updated: March 4, 2013
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome X

Intervention

Other:
• isocaloric diet

• free living conditions

Locations

Country	Name	City	State
Canada	Institute of Nutraceutical and Functional Foods (INAF), Laval University	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma LDL, TG and HDL-C		Week 5, 10 and 35 (at the end of each weight-maintaining diet)	No
Secondary	CRP, and blood pressure, kinetic of lipoproteins		Week 5, 10 and 35 (at the end of each weight-maintaining diet)	No