Hypertriglyceridemia is a significant risk factor for cardiovascular diseases. Omega-3 fatty acids have been shown to reduce triglyceride levels, and their combination with phospholipids could offer additional benefits in improving lipid profiles and inflammatory markers. This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence on the benefits of this combination in improving lipid profiles and reducing inflammation, which could have a significant impact on clinical practices and future dietary recommendations.
This study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. The objective of the clinical trial is to provide robust evidence of the benefits of this combination in improving lipid profiles and reducing inflammation, which could significantly impact clinical practices and future dietary recommendations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Intervention Arm: Omega-3 + Phospholipids.
Comparator Arm: Omega-3 alone.
Fundacion del Caribe para la Investigación Biomedica
Barranquilla, Atlántico, Colombia
Reduction in Triglyceride Levels
Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.
Time frame: 12 weeks
Reduction in Inflammatory Markers
Assess changes in levels of inflammatory markers such as High Sensivity CRP (C-reactive protein) and IL-6 (interleukin-6) from baseline to 12 weeks.
Time frame: 12 weeks
Improvement in HOMA-IR Index
Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks.
Time frame: 12 weeks
Improvement in Omega Index
Assess changes in the Omega Index (percentage of omega-3 fatty acids in red blood cell membranes) from baseline to 12 weeks.
Time frame: 12 weeks
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