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Completed

NCT Number: NCT00988650

Mediterranean Diet and the Metabolic Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

isocaloric diet

Other

Other names: 3 isocaloric die

free living conditions

Other

Other names: weight lost free living conditions

Primary outcomes

  1. plasma LDL, TG and HDL-C

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

Secondary outcomes

  1. CRP, and blood pressure, kinetic of lipoproteins

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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: MedDiet

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2009
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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