Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00296595
First received: February 9, 2006
Last updated: February 25, 2010
Last verified: February 2006

February 9, 2006
February 25, 2010
February 2006
December 2008   (final data collection date for primary outcome 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 [ Time Frame: June 2008 ]
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
Complete list of historical versions of study NCT00296595 on ClinicalTrials.gov Archive Site
Changes in arterial flow-mediated vasodilatory response [ Time Frame: June 2008 ]
Changes in arterial flow-mediated vasodilatory response
Not Provided
Not Provided
 
Effects of n-3 Polyunsaturated Fatty Acids and Antioxidants on Postprandial Hyperlipidemia and Vascular Function in Men
Physiological Mechanisms Underlying the Effects of PUFA and Antioxidants on Postprandial Lipemia, Oxidative Stress, Endothelial Dysfunction and Inflammation in Men

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Vasodilation
Behavioral: Nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Waist circumference > 90 cm
  • Fasting triglycerides > 1.7 mmol/L
  • No use (ever) of medications for the treatment for dyslipidemia or hypertension

Exclusion Criteria:

  • 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.
  • Chronic use of supplements (vitamins, minerals or flavonoids)
  • Body mass index > 35 kg/m2
  • Chronic diseases: CHD, diabetes, etc.
  • Smokers (1 or more cigarette/day)
  • Dyslipidemia secondary to renal insufficiency, hypothyroidism or others
  • 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.
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00296595
MOP-64438
Not Provided
Charles Couillard, Associate Professor, Laval University
Laval University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Charles Couillard, Ph.D. Laval University
Laval University
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP