Evaluation of the Efficacy of Omega + Phospholipids Vs. Omega Alone in Patients with Hypertriglyceridemia: Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Hypertriglyceridemia

• Registration Number: NCT06749028
• Lead Sponsor: Fundación del Caribe para la Investigación Biomédica

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-17
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients aged ≥18 to 65 years.
• Triglyceride levels ≥ 150 mg/dL and ≤ 500 mg/dL.
• Signed informed consent.

Exclusion Criteria

• Use of omega-3 supplements in the last 3 months.
• Use of any lipid-lowering medication.
• Known allergy to the components of the treatment.
• Uncontrolled chronic diseases (e.g., renal failure, liver disease).
• Any type of cancer.
• Undergoing treatment for HIV.
• Pregnancy or breastfeeding.
• Use of substances or prescribed medications that may increase triglyceride levels (e.g., estrogens, atypical antipsychotics, etc.). -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Triglyceride Levels	12 weeks	Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Reduction in Inflammatory Markers	12 weeks	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.
Improvement in HOMA-IR Index	12 weeks	Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks.
Improvement in Omega Index	12 weeks	Assess changes in the Omega Index (percentage of omega-3 fatty acids in red blood cell membranes) from baseline to 12 weeks.

Trial Locations

Locations (1)

Fundacion del Caribe para la Investigación Biomedica; 🇨🇴 Barranquilla, Atlantico, Colombia