Evaluation of the Efficacy of Phospholipid-Bound Omega-3 Versus Omega-3 Alone in Patients With Hypertriglyceridemia: A Randomized Clinical Trial (OMEGA-PHYT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: Comparator Arm: Omega-3 alone.; Dietary supplement: Intervention Arm: Omega-3 + Phospholipids.

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Fundación del Caribe para la Investigación Biomédica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B: Comparator Arm: Omega-3 alone.; Comparator Arm: Omega-3 alone	Dietary supplement: Comparator Arm: Omega-3 alone.; Comparator Arm: Omega-3 alone.
Experimental: Group A: Intervention Arm: Omega-3 + Phospholipids.; Intervention Arm: Omega-3 + Phospholipids.	Dietary supplement: Intervention Arm: Omega-3 + Phospholipids.; Intervention Arm: Omega-3 + Phospholipids.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Improvement in HOMA-IR Index	Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Fundación del Caribe para la Investigación Biomédica
• Collaborators: Naturmega
• Investigators: Principal Investigator: Miguel A Urina, PhD, Fundación del Caribe para la Investigación Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): May 20, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hypertriglyceridemia
• Other Study ID Numbers: 202401OMEGA-PHYT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Purpose of Data Sharing: Explain why the personal data will be shared, such as to foster collaboration on additional research, validate results, or conduct broader analyses.; Types of Data to be Shared: Describe the types of personal or sensitive data that will be shared, ensuring that only the necessary data for research will be provided.; Confidentiality and Security Measures: Detail how personal data will be protected to ensure the privacy and confidentiality of participants. This could include anonymizing or pseudonymizing the data, using secure platforms for data exchange, and complying with legal regulations such as the General Data Protection Regulation (GDPR).; Requirements for Researchers Receiving the Data: Specify the requirements for researchers receiving the data, such as signing confidentiality agreements and committing to use the data solely for the agre
• IPD Sharing Time Frame: 12 months

IPD Sharing Access Criteria

1. Who Will Have Access:

   • Principal Investigators (PIs) and Research Team
   • Collaborating Researchers
   • Regulatory Authorities

2. What They Will Be Able to Access:

   Personal Data Study Data Supporting Information

3. How They Will Be Able to Access It:

Secure Data Platforms Access Request Process Data Access Agreements Anonymized or De-identified Data

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No