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NCT Number: NCT06749028

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion del Caribe para la Investigación Biomedica

Barranquilla, Atlántico, 080020, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.). -

Treatment and study plan

Intervention Arm: Omega-3 + Phospholipids.

Dietary Supplement

Intervention Arm: Omega-3 + Phospholipids.

Comparator Arm: Omega-3 alone.

Dietary Supplement

Comparator Arm: Omega-3 alone.

Primary outcomes

  1. Reduction in Triglyceride Levels

    Time frame: 12 weeks

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

Secondary outcomes

  1. Reduction in Inflammatory Markers

    Time frame: 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.

  2. Improvement in HOMA-IR Index

    Time frame: 12 weeks

    Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks.

  3. Improvement in Omega Index

    Time frame: 12 weeks

    Assess changes in the Omega Index (percentage of omega-3 fatty acids in red blood cell membranes) from baseline to 12 weeks.

Sponsors and collaborators

Lead sponsor

Fundación del Caribe para la Investigación Biomédica

Other

Collaborators

  • Naturmega

Registry information

Acronym: OMEGA-PHYT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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