NCT01089231

Effects of Omega-3 Fatty Acids on the Human Gene Expression

Effects of Omega-3 Fatty Acids From Fish Oil on the Gene Expression in Healthy Humans and Humans With Hypertriglyceridemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gottfried Wilhelm Leibniz Universität Hannover · Academic / Other
• Sex: Male
• Age: 20 Years – 51 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the effects of short- and long-term intervention with EPA and DHA-rich fish oil on gene expression profiles in healthy and hyperlipidemic males.

Detailed description

Cardiovascular and coronary heart diseases continue to be the leading causes of morbidity and mortality among adults in Europe and North America. Since the number of elderly people and therefore the number of chronic-inflammatory diseases rise, preventive therapies become more important. Within preventive strategies, nutrition plays a central role. Cross-sectional studies suggested that omega-3 fatty acids, especially the very long-chain fatty acids Eicosapentaenoic acid (EPA, C20:5ω3) and Docosahexaenoic acid (DHA, C22:6ω3), are protective against cardiovascular and coronary heart diseases. Their cardio protective potential is based on their positive effects on blood lipids, vascular tonus and blood clotting. A number of controlled clinical trials have shown that EPA and DHA supplementation lower fasting and postprandial plasma concentrations of triglyceride-rich lipoproteins and their remnants. Biochemical research revealed numerous metabolic effects of EPA and DHA, ranging from their effects on membrane fluidity to the modification of the eicosanoid profile. However, only a few human clinical trials examined the regulative effects of DHA and EPA supplementation on gene expression. Furthermore, to our knowledge no published research data is available dealing with the effect of these fatty acids on gene expression in subjects with hypertriglyceridemia in comparison to healthy subjects. Such findings are of great concern due to hints that especially people with hypertriglyceridemia benefit from the triglyceride lowering effect of EPA and DHA supplementation. Presently it is not well-established if the gene regulative potential of EPA and DHA in these persons differs from healthy persons. These findings could help to understand the differences in the metabolic effects of EPA and DHA in healthy vs. hypertriglyceridemic persons, which have a greater risk for cardiovascular and coronary diseases. Finally, these data could contribute to a knowledge basis for targeted strategies in preventive therapies with the very long-chain omega-3 fatty acids EPA and DHA.

Conditions

• Hyperlipidemia
• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish oil	Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months
DIETARY_SUPPLEMENT	Placebo (corn oil)	corn oil (6 capsules per day)

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-07-01
• Completion: 2011-07-01
• First posted: 2010-03-18
• Last updated: 2011-12-19
• Results posted: 2011-12-02

Locations

1 site across 1 country: Germany