Background Hypertriglyceridemia is an independent risk factor for coronary artery disease (CAD). Although lower levels of hypertriglyceridemia increase the risk of CAD, these levels do not attain much clinical attention until they exceed 400 mg/dL. Dietary supplements are attractive options for treating triglyceride levels below 400 mg/dL that do not qualify for drug therapy. Most studies on omega-3 fatty acids (OM-3 FA) and hypertriglyceridemia were performed using a higher dose of OM-3 FA. There are no data on the effects of a low dose of OM-3 FA on hypertriglyceridemia. In this study, we test the effects of 1 g of eicosapentaenoic acid/docosahexaenoic acid (EPA/DHA) taken daily on triglyceride levels.
Methods A randomized placebo-controlled trial was conducted at an outpatient community university clinic. Fifty patients with hypertriglyceridemia were randomly selected. Inclusion Criteria: (1) Patients with a triglyceride level above 200 mg/dL, (2) active community patients, (3) any gender, race, or geographic location of residence could be included in the study. Exclusion Criteria: (1) Patients under 18 years of age, (2) patients with a triglyceride level of 500 mg/dL or above, (3) patients for whom, according to the evaluating physician, further drug treatment is required to lower triglyceride level and improve cardiovascular risk, (4) patients who are allergic to fish, (5) patients who are on any triglyceride-lowering drug. The study period was 12 weeks. Baseline and 12-week lipid profile and hs-CRP were obtained. Carlson Lab Inc. provided 50 bottles of softgels. Each bottle contained 180 softgel of 300 mg of EPA and 200 mg of DHA or 180 similar-appearing placebo softgel. Patients were assigned randomly to the treatment or placebo bottles.
Results A total of 39 patients met all of the criteria. Eighteen patients received EPA/DHA and 21 received placebo. The mean reduction in the triglyceride level in the treatment arm was 79 mg/dL compared with 49 mg/dL in the placebo arm. There was no statistical difference in triglyceride reduction between the two arms (p = .23). Among all patients (in both arms), there was no significant difference in BMI before and after treatment. Furthermore, compared with placebo, 1 g of OM-3 FA given daily showed no significant reduction in hs-CRP.
Conclusion EPA/DHA at 1 g daily does not provide significant reduction of triglyceride level or hs-CRP. Although our study does not add much to the management of hypertriglyceridemia or high-risk cardiovascular patients, this pilot project may lead to other studies addressing the lowest effective dose of OM-3 FA for lipid lowering and overall cardiovascular protection.
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