Healthy Clinical Trial
Official title:
Effects of Omega-3 Fatty Acids From Fish Oil on the Gene Expression in Healthy Humans and Humans With Hypertriglyceridemia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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