Clinical trial NCT06749028: Evaluation of the Efficacy of Omega + Phospholipids Vs. Omega Alone in Patients with Hypertriglyceridemia: Randomized Clinical Trial
Official title: Evaluation of the Efficacy of Omega-3 Plus Phospholipids Vs. Omega-3 Alone in Patients with Hypertriglyceridemia: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3
Lead sponsor: Fundación del Caribe para la Investigación Biomédica
Sponsor class: OTHER
Collaborators: name: Naturmega
First posted: 2024-12-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.). -

Primary outcomes:
measure: Reduction in Triglyceride Levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in Inflammatory Markers
timeFrame: 12 weeks
measure: Improvement in HOMA-IR Index
timeFrame: 12 weeks
measure: Improvement in Omega Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Fundacion del Caribe para la Investigación Biomedica
state: Atlantico
Study officials:
affiliation: Fundacion del Caribe para la investigación Biomedica
name: Miguel A Urina, PhD
role: PRINCIPAL_INVESTIGATOR
References: