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

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ClinicalTrials.gov Identifier: NCT00296595
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Vasodilation Behavioral: Nutrition Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Physiological Mechanisms Underlying the Effects of PUFA and Antioxidants on Postprandial Lipemia, Oxidative Stress, Endothelial Dysfunction and Inflammation in Men
Study Start Date : February 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules + 500 mL/day of placebo juice
Behavioral: Nutrition
Experimental: Cranberry Juice
Placebo capsules + 500 mL/day of cranberry juice
Behavioral: Nutrition
Experimental: Fish Oil
2 g/day of fish oil + 500 mL/day of placebo juice
Behavioral: Nutrition
Experimental: Cranberry Juice + Fish Oil
2 g/day of fish oil + 500 mL/day of cranberry juice
Behavioral: Nutrition


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in arterial flow-mediated vasodilatory response [ Time Frame: June 2008 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296595


Locations
Canada
Institute of Nutraceuticals and Functional Foods
Quebec, Canada, G1K 7P4
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Charles Couillard, Ph.D. Laval University
More Information

Publications:
Responsible Party: Charles Couillard, Professor, Laval University
ClinicalTrials.gov Identifier: NCT00296595     History of Changes
Other Study ID Numbers: MOP-64438
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs