Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT00988650
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2009-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and the Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma LDL, TG and HDL-C', 'timeFrame': 'Week 5, 10 and 35 (at the end of each weight-maintaining diet)'}], 'secondaryOutcomes': [{'measure': 'CRP, and blood pressure, kinetic of lipoproteins', 'timeFrame': 'Week 5, 10 and 35 (at the end of each weight-maintaining diet)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Mediterranean diet', 'Blood lipids', 'Coronary heart disease', 'Apolipoprotein'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '25011605', 'type': 'DERIVED', '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.'}, {'pmid': '24499022', 'type': 'DERIVED', '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.'}, {'pmid': '24265415', 'type': 'DERIVED', '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.'}, {'pmid': '23505168', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men from the Québec City metropolitan area with the metabolic syndrome based on the NCEP-ATP III definition (3 criteria or more see below):\n* Waist circumference ≥ 102 cm\n* Triglycerides ≥ 1.7 mmol/L\n* HDL-cholesterol \\<= 1.04 mmol/L\n* Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg\n* Fasting blood glucose ≥ 5.6 mmol/L\n* Stable body weight (+/- 2 kg) for 6 months before the beginning of the study\n\nExclusion Criteria:\n\n* Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia\n* Subjects taking medications for hyperlipidemia or hypertension\n* Endocrine disorders\n* Food allergies or aversion for specific components of the MedDiet\n* Smokers\n* Consummation excessive of alcohol (\\> 2 consummation/day)'}, 'identificationModule': {'nctId': 'NCT00988650', 'acronym': 'MedDiet', 'briefTitle': 'Mediterranean Diet and the Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Mechanistic Investigation of the Mediterranean Diet and Its Impact on the Metabolic Syndrome in Men', 'orgStudyIdInfo': {'id': 'INAF-2006-277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'North American diet', 'description': 'Control North American diet for five weeks in isocaloric conditions', 'interventionNames': ['Other: isocaloric diet']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet', 'description': 'Mediterranean diet for five weeks in isocaloric conditions', 'interventionNames': ['Other: isocaloric diet']}, {'type': 'EXPERIMENTAL', 'label': 'weight loss period', 'description': 'Weight loss period of 20-week (minimum 5% reduction in body weight)', 'interventionNames': ['Other: free living conditions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight stabilizing mediterranean diet', 'description': 'Mediterranean diet for five weeks in isocaloric weight stabilizing conditions', 'interventionNames': ['Other: isocaloric diet']}], 'interventions': [{'name': 'isocaloric diet', 'type': 'OTHER', 'otherNames': ['3 isocaloric die'], 'armGroupLabels': ['Mediterranean diet', 'North American diet', 'Weight stabilizing mediterranean diet']}, {'name': 'free living conditions', 'type': 'OTHER', 'otherNames': ['weight lost free living conditions'], 'armGroupLabels': ['weight loss period']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute of Nutraceutical and Functional Foods (INAF), Laval University', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Benoît Lamarche, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Nutraceutical and Functional Foods (INAF), Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benoit Lamarche', 'investigatorAffiliation': 'Laval University'}}}}