Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT00296595
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2006-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-24', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in postprandial lipemia, oxidative stress, endothelial activation and inflammation: TG (plasma, chylomicron and VLDL), OxLDL, 8-iso-PGF2alpha, ICAM-1, VCAM-1, E-selectin and CRP concentrations', 'timeFrame': 'June 2008'}], 'secondaryOutcomes': [{'measure': 'Changes in arterial flow-mediated vasodilatory response', 'timeFrame': 'June 2008'}]}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Vasodilation']}, 'referencesModule': {'references': [{'pmid': '15988692', 'type': 'BACKGROUND', 'citation': 'Ruel G, Pomerleau S, Couture P, Lamarche B, Couillard C. Changes in plasma antioxidant capacity and oxidized low-density lipoprotein levels in men after short-term cranberry juice consumption. Metabolism. 2005 Jul;54(7):856-61. doi: 10.1016/j.metabol.2005.01.031.'}, {'pmid': '16189262', 'type': 'BACKGROUND', 'citation': 'Couillard C, Ruel G, Archer WR, Pomerleau S, Bergeron J, Couture P, Lamarche B, Bergeron N. Circulating levels of oxidative stress markers and endothelial adhesion molecules in men with abdominal obesity. J Clin Endocrinol Metab. 2005 Dec;90(12):6454-9. doi: 10.1210/jc.2004-2438. Epub 2005 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'Diet has long been used as a way to provide enough nutrients to an individual in order to meet metabolic requirements. However, recent scientific advancements have suggested that beyond meeting nutrition needs, diet may also be health promoting through the modulation of various body functions. In a way, the role of nutrition has evolved from hunger satisfaction and maintenance of body integrity to the promotion of a state of well-being and prevention of important chronic diseases such as cancer, diabetes and cardiovascular disease (CVD). In recent years, n-3 polyunsaturated fatty acids (PUFA) have attracted much attention as consumption of a n-3 PUFA rich diet has been reported to reduce CVD risk. However, n-3 PUFA are also highly susceptible to free radical damage and therefore could be unable to fully exert their health benefits under an oxidative stress condition. The general objective of the present application is to investigate the mechanisms by which n-3 PUFA improve cardiovascular health in abdominal obesity and explore the potential of dietary antioxidants to modulate these effects in individuals at high risk of oxidative stress. For that purpose, we plan to study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks of n-3 PUFA supplementation with or without low-calorie cranberry juice cocktail (as a source of antioxidants) in a group of 160 men. We feel that the present study will broaden our understanding of the physiological mechanisms underlying the beneficial effects of consuming unsaturated fatty acids and give further insights on the role of antioxidants in preserving and potentiating these cardiovascular health benefits.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Waist circumference \\> 90 cm\n* Fasting triglycerides \\> 1.7 mmol/L\n* No use (ever) of medications for the treatment for dyslipidemia or hypertension\n\nExclusion Criteria:\n\n* Alcohol consumption \\> 1 drink per day i.e \\~15 g of alcohol/day or the equivalent of 1 beer (12 oz or 341 mL), 1 glass of wine (4 oz or 125 mL) or 1 ounce (30 mL) of liquor.\n* Chronic use of supplements (vitamins, minerals or flavonoids)\n* Body mass index \\> 35 kg/m2\n* Chronic diseases: CHD, diabetes, etc.\n* Smokers (1 or more cigarette/day)\n* Dyslipidemia secondary to renal insufficiency, hypothyroidism or others\n* Any prior or current use of medications known to affect lipoprotein-lipid metabolism (e.g. statins, fibrates), endothelial function (hypotensive drugs). Use (ever) of anticoagulant drugs (e.g. warfarin) because of possible detrimental interaction with the consumption of cranberry juice. Current or recent (\\<2 weeks) use of anti-inflammatory drugs Note: If for any reason, a subject would have to go an any of these drugs during the protocol, they would be automatically dropped from the study.'}, 'identificationModule': {'nctId': 'NCT00296595', 'briefTitle': 'Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Physiological Mechanisms Underlying the Effects of PUFA and Antioxidants on Postprandial Lipemia, Oxidative Stress, Endothelial Dysfunction and Inflammation in Men', 'orgStudyIdInfo': {'id': 'MOP-64438'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules + 500 mL/day of placebo juice', 'interventionNames': ['Behavioral: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Cranberry Juice', 'description': 'Placebo capsules + 500 mL/day of cranberry juice', 'interventionNames': ['Behavioral: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Fish Oil', 'description': '2 g/day of fish oil + 500 mL/day of placebo juice', 'interventionNames': ['Behavioral: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Cranberry Juice + Fish Oil', 'description': '2 g/day of fish oil + 500 mL/day of cranberry juice', 'interventionNames': ['Behavioral: Nutrition']}], 'interventions': [{'name': 'Nutrition', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cranberry Juice', 'Cranberry Juice + Fish Oil', 'Fish Oil', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1K 7P4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute of Nutraceuticals and Functional Foods', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Charles Couillard, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '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': 'Charles Couillard', 'investigatorAffiliation': 'Laval University'}}}}