NCT01233778

Canola Oil Multicentre Intervention Trial (COMIT)

Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.

Detailed description

The consequence of total fat consumption on circulating plasma lipids and the incidence of cardiovascular disease has long been a central theme in nutrition research. Less well known is the influence of specific fatty acids on vascular endothelial function and the oxidative and inflammatory responses characteristic of atherogenesis. Omega 3 ( ω-3) fatty acids, including plant derived alpha-linolenic acid (18:3n-3, ALA) and marine derived eicosapentaenoic (20:5n-3, EPA) and docosahexaenoic acid (22:6n-3, DHA) have been shown to effectively modulate multiple cardiovascular risk factors in epidemiological, animal model and human clinical investigations. ALA is most commonly consumed as a major component of dietary canola and flaxseed oils and has a recommended intake of 1.1 and 1.6 g/d for women and men, respectively. EPA and DHA are consumed as fatty fish or fish oil and algae supplements with current recommended intakes of 500 mg/d (combined EPA and DHA). ALA is thought to improve cardiovascular health by modulating circulating lipid concentrations, altering membrane structure and function by enhancing the total ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by blocking the formation of arachidonic acid derived eicosanoids. However, there are extensive knowledge gaps in our understanding of the molecular mechanisms and clinical efficacy of ω-3 fatty acids in human health and disease prevention. Therefore, the purpose of this study is to further examine these relationships. Feeding protocol and study treatments: The study will proceed as a double blind, randomized cross-over controlled feeding study. Each treatment phase will be 30 days in duration, separated by 4-week washout periods. Subjects will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate, and 15% protein) supplemented with 60g/d of the following treatment oils: 1) canola oil; 2) DHA enriched canola-oil; 3) high oleic acid canola oil; 4) flax/corn oil (40:60); or 5) safflower/corn oil (75:25). Study diets will be prepared in a metabolic kitchen facility at each clinical site. Three isocaloric meals will be prepared each day for every subject. A 7-day rotating menu cycle will be used. Subjects will consume at least 1 of 3 daily meals under supervision. The other meals will be prepared and packed for every subject to be taken out. The study control and intervention oils will be delivered in milkshakes provided twice daily. Subjects will be instructed to consume only the prepared meals and limit their intake of alcohol to 2 drinks/week and caffeinated calorie free beverages to 40oz (5 drinks) per day. Diets will be planned for every subject according to his/her energy requirements and will be nutritionally adequate.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Canola Oil	60g Canola oil daily per 3000kcal diet provided in a supplemental shake
DIETARY_SUPPLEMENT	High Oleic Acid + DHA Canola Oil	60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake
DIETARY_SUPPLEMENT	High Oleic Acid Canola Oil	60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake
DIETARY_SUPPLEMENT	Flax Oil	36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake
DIETARY_SUPPLEMENT	Safflower Oil	45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2010-11-03
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States