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Mediterranean Diet and the Metabolic Syndrome (MedDiet)

Primary Purpose

Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
isocaloric diet
free living conditions
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Metabolic syndrome, Mediterranean diet, Blood lipids, Coronary heart disease, Apolipoprotein

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

North American diet

Mediterranean diet

weight loss period

Weight stabilizing mediterranean diet

Arm Description

Control North American diet for five weeks in isocaloric conditions

Mediterranean diet for five weeks in isocaloric conditions

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

Mediterranean diet for five weeks in isocaloric weight stabilizing conditions

Outcomes

Primary Outcome Measures

plasma LDL, TG and HDL-C

Secondary Outcome Measures

CRP, and blood pressure, kinetic of lipoproteins

Full Information

First Posted
September 25, 2009
Last Updated
March 4, 2013
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00988650
Brief Title
Mediterranean Diet and the Metabolic Syndrome
Acronym
MedDiet
Official Title
Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease
Keywords
Metabolic syndrome, Mediterranean diet, Blood lipids, Coronary heart disease, Apolipoprotein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
North American diet
Arm Type
Active Comparator
Arm Description
Control North American diet for five weeks in isocaloric conditions
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm Description
Mediterranean diet for five weeks in isocaloric conditions
Arm Title
weight loss period
Arm Type
Experimental
Arm Description
Weight loss period of 20-week (minimum 5% reduction in body weight)
Arm Title
Weight stabilizing mediterranean diet
Arm Type
Active Comparator
Arm Description
Mediterranean diet for five weeks in isocaloric weight stabilizing conditions
Intervention Type
Other
Intervention Name(s)
isocaloric diet
Other Intervention Name(s)
3 isocaloric die
Intervention Type
Other
Intervention Name(s)
free living conditions
Other Intervention Name(s)
weight lost free living conditions
Primary Outcome Measure Information:
Title
plasma LDL, TG and HDL-C
Time Frame
Week 5, 10 and 35 (at the end of each weight-maintaining diet)
Secondary Outcome Measure Information:
Title
CRP, and blood pressure, kinetic of lipoproteins
Time Frame
Week 5, 10 and 35 (at the end of each weight-maintaining diet)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît Lamarche, PhD
Organizational Affiliation
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Nutraceutical and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25011605
Citation
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.
Results Reference
derived
PubMed Identifier
24499022
Citation
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.
Results Reference
derived
PubMed Identifier
24265415
Citation
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.
Results Reference
derived
PubMed Identifier
23505168
Citation
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.
Results Reference
derived

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Mediterranean Diet and the Metabolic Syndrome

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