Hypertriglyceridemia Clinical Trial
Official title:
Effect of Docosahexenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for Cardiovascular Disease in Hyperlipidemic Men
The purpose of this study is to determine the effects of supplementing diets of hyperlipidemic men with DHA (docosahexenoic acid) on risk factors for cardiovascular disease. We hypothesize that supplementing diets of hyperlipidemic men with DHA will decrease the plasma concentrations of CRP (C-reactive protein), inflammatory cytokines, and soluble adhesion molecules. We further hypothesize that DHA supplementation will decrease serum triglyceride concentrations and increase HDL concentration.
Cardiovascular disease (CVD) and stroke are the leading causes of mortality in the United
States, accounting for more than 38% of all deaths. Elevated total- and LDL- cholesterol,
number of total and small dense LDL particles, triacylglycerols, and low HDL-C are
established independent risk factors for the development of CVD. Additional novel blood
lipid markers used as risk factors for CVD include, increased plasma concentration of
remnant like particle-cholesterol (RLP-C), decreased ratio between plasma eicosapentaenoic
acid (EPA) and arachidonic acd (AA), and decreased omega-3 index (sum of EPA and DHA as a
percentage of total fatty acid content) of the red blood cells.
Diets rich in omega-3 fatty acids have been shown to be cardio-protective; these diets
decreased inflammation, platelet aggregation, cardiac arrhythmias, triglycerides, number of
total LDL and small dense LDL particles, and increased omega-3 index, endothelial relaxation
and atherosclerotic plaque stability. Most of the earlier studies regarding the effects of
long chain n-3 PUFA on blood lipids were conducted with fish oils which contain a mixture of
EPA and DHA. Recently a number of studies have been conducted with EPA and DHA individually.
Results from studies with individual fatty acids show that EPA and DHA have similar effects
on some of the lipid parameters, but they are assimilated to a different concentration in
tissues and have different effects on lipoprotein particle size, heart rate and blood
pressure. The main purpose of this study is to examine the effects of DHA supplementation on
the above three risk factors.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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