Efficacy of phospholipid-bound omega-3 versus standard omega-3 in patients with hypertriglyceridemia: a randomized clinical trial
Abstract
BACKGROUND: Hypertriglyceridemia is a modifiable risk factor for cardiovascular disease, and while omega-3 fatty acids (omega-3 FAs) are known to lower triglyceride (TG) concentrations, their effectiveness is influenced by formulation and bioavailability. Phospholipid-bound (PL) omega-3 FAs—such as those found in krill oil—demonstrate superior intestinal absorption and membrane integration compared with TG- and ethyl ester omega-3 FAs based forms. Preclinical studies have shown that PL omega-3 FAs exhibit anti-inflammatory, antithrombotic, and TG-lowering properties; however, clinical data remain limited. This pilot randomized clinical trial compared the efficacy of PL omega-3 FAs with standard omega-3 FAs in patients with mild to moderate hypertriglyceridemia. METHODS: We performed a randomized, controlled, double-blind, parallel-group pilot trial involving patients aged 18–65 years with fasting TG between 150 and 499 mg/dL. Patients were randomized to receive PL omega-3 FAs (eicosapentaenoic acid [EPA) + docosahexaenoic acid [DHA), 825 mg/day) or standard omega-3 FAs (EPA + DHA, 903 mg/day). Primary outcomes were changes in fasting TG and omega-3 index (O3I) after 12 weeks. Secondary outcomes included changes in lipid profile, glycemic markers, inflammatory markers, anthropometric measures, hemodynamic variables, and safety parameters. RESULTS: Of the 47 randomized participants, 44 (22 per group) completed the study and were included in the analysis. Mean TG levels…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 47 participants or records.
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