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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2025-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Group B: Comparator Arm: Omega-3 alone.

Comparator Arm: Omega-3 alone

Group Type ACTIVE_COMPARATOR

Comparator Arm: Omega-3 alone.

Intervention Type DIETARY_SUPPLEMENT

Comparator Arm: Omega-3 alone.

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

Intervention Arm: Omega-3 + Phospholipids.

Group Type EXPERIMENTAL

Intervention Arm: Omega-3 + Phospholipids.

Intervention Type DIETARY_SUPPLEMENT

Intervention Arm: Omega-3 + Phospholipids.

Interventions

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Intervention Arm: Omega-3 + Phospholipids.

Intervention Type DIETARY_SUPPLEMENT

Comparator Arm: Omega-3 alone.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.). -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No