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

NCT00296595 | Completed Phase 2

• 1 other identifier: MOP-64438
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Vasodilation

Outcome Measures

Primary Outcomes (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

  June 2008

Secondary Outcomes (1)

• Changes in arterial flow-mediated vasodilatory response

  June 2008

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo capsules + 500 mL/day of placebo juice

Behavioral: Nutrition

Cranberry Juice

EXPERIMENTAL

Placebo capsules + 500 mL/day of cranberry juice

Behavioral: Nutrition

Fish Oil

EXPERIMENTAL

2 g/day of fish oil + 500 mL/day of placebo juice

Behavioral: Nutrition

Cranberry Juice + Fish Oil

EXPERIMENTAL

2 g/day of fish oil + 500 mL/day of cranberry juice

Behavioral: Nutrition

Interventions

Nutrition BEHAVIORAL

Cranberry Juice; Cranberry Juice + Fish Oil; Fish Oil; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institute of Nutraceuticals and Functional Foods

Québec, Quebec, G1K 7P4, Canada

Location

Related Publications (2)

• 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: 15988692 BACKGROUND

• 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.

  PMID: 16189262 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Aneurysm

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Charles Couillard, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 27, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

CA (1)