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

NCT06749028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Intervention Arm: Omega-3 + Phospholipids.

Intervention Arm: Omega-3 + Phospholipids.

DIETARY_SUPPLEMENT

Comparator Arm: Omega-3 alone.

Comparator Arm: Omega-3 alone.

Sponsors & Collaborators

  • Naturmega

    collaborator UNKNOWN

  • Fundación del Caribe para la Investigación Biomédica

    lead OTHER

Principal Investigators

  • Miguel A Urina, PhD · Fundacion del Caribe para la investigación Biomedica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-05-20
Completion
2025-08-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06749028 on ClinicalTrials.gov