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

Fundación del Caribe para la Investigación Biomédica

Status: Active, not recruiting

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: Comparator Arm: Omega-3 alone.; Dietary Supplement: Intervention Arm: Omega-3 + Phospholipids.

Study type: Interventional

Funder types: Other

Identifiers

NCT06749028

202401OMEGA-PHYT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.). -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Group B: Comparator Arm: Omega-3 alone.

Active Comparator group

Description:

Comparator Arm: Omega-3 alone

Treatment:

Dietary Supplement: Comparator Arm: Omega-3 alone.

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

Experimental group

Description:

Intervention Arm: Omega-3 + Phospholipids.

Treatment:

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