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

NCT06749028 | Active Not Recruiting

• 1 other identifier: 202401OMEGA-PHYT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3

Outcome Measures

Primary Outcomes (1)

• Reduction in Triglyceride Levels

  Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks.

  12 weeks

Secondary Outcomes (3)

• Reduction in Inflammatory Markers

  12 weeks

• Improvement in HOMA-IR Index

  12 weeks

• Improvement in Omega Index

  12 weeks

Study Arms (2)

Group B: Comparator Arm: Omega-3 alone.

ACTIVE COMPARATOR

Comparator Arm: Omega-3 alone

Dietary Supplement: Comparator Arm: Omega-3 alone.

Group A: Intervention Arm: Omega-3 + Phospholipids.

EXPERIMENTAL

Intervention Arm: Omega-3 + Phospholipids.

Dietary Supplement: Intervention Arm: Omega-3 + Phospholipids.

Interventions

Intervention Arm: Omega-3 + Phospholipids. DIETARY_SUPPLEMENT

Intervention Arm: Omega-3 + Phospholipids.

Group A: Intervention Arm: Omega-3 + Phospholipids.

Comparator Arm: Omega-3 alone. DIETARY_SUPPLEMENT

Comparator Arm: Omega-3 alone.

Group B: Comparator Arm: Omega-3 alone.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.). -

Sponsors & Collaborators

• Fundación del Caribe para la Investigación Biomédica: lead
• Naturmega: collaborator

Study Sites (1)

Fundacion del Caribe para la Investigación Biomedica

Barranquilla, Atlántico, 080020, Colombia

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Phospholipids

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Membrane Lipids; Lipids

Study Officials

• Miguel A Urina, PhD

  Fundacion del Caribe para la investigación Biomedica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to the parties commonly masked in this clinical trial(e.g., participants, investigators, and outcome assessors), other parties be masked include: 1. Data Analysts: If feasible, data analysts will be blinded to the intervention groups during data analysis to reduce bias in interpreting results. 2. Study Coordinators or Site Staff: Those responsible for enrolling participants or managing study logistics will be masked to intervention assignments to prevent unintentional influence on participant behavior. 3. Pharmacists or Treatment Preparers: Pharmacists will be blinded to the allocation of active versus placebo treatments 4. Regulatory Reviewers or Monitors: External reviewers or monitors who audit the study will be masked to treatment allocation to ensure unbiased oversight. 5. Statistical Reviewers for Interim Analyses: the statisticians conducting these will be masked to group allocations to preserve trial integrity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PICOT * Population:Adult patients ≥ 18 years old diagnosed with hypertriglyceridemia, defined as triglycerides \>150 mg/dL. * Intervention: Omega-3 + phospholipids. * Comparator: Omega-3. * Outcome: Reduction in triglyceride levels and inflammatory markers, improvement in HOMA-IR index, and Omega Index. * Time:12 weeks.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: December 17, 2024
• Primary Completion: May 20, 2025
• Study Completion: August 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months
• 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

Locations

CO (1)