Hypertriglyceridemia
Conditions
Keywords
hypertriglyceridemia;Fatty Acids, Omega-3;phospholipids, Omega-3
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.
Interventions
DIETARY_SUPPLEMENTIntervention Arm: Omega-3 + Phospholipids.
Intervention Arm: Omega-3 + Phospholipids.
DIETARY_SUPPLEMENTComparator Arm: Omega-3 alone.
Comparator Arm: Omega-3 alone.
Sponsors
Naturmega
Fundación del Caribe para la Investigación Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.). -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Triglyceride Levels | 12 weeks | Description: Evaluate the change in triglyceride levels (mg/dL) from baseline to 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Inflammatory Markers | 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. |
| Improvement in HOMA-IR Index | 12 weeks | Measure changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to 12 weeks. |
| Improvement in Omega Index | 12 weeks | Assess changes in the Omega Index (percentage of omega-3 fatty acids in red blood cell membranes) from baseline to 12 weeks. |
Countries
Colombia
Outcome results
None listed