Effect of Omega 3 in Hypertensive Patients (OMECARDIO)

Santa Maria de la Salud, Argentina

Status: Completed

Conditions: Hypertension; Dyslipidemia

Treatments: Dietary Supplement: omega 3 ethyl esters at 90%; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06840964

20220325

Details and patient eligibility

About

This study aims to evaluate the impact of omega-3 (O3) supplementation in participants with high blood pressure and elevated triglycerides, focusing on cardiovascular risk factors. The research is particularly relevant, as O3 has been previously validated for its effects on abnormal lipid levels. The primary and secondary objectives aim to explore the effects of O3, as well as its potential therapeutic benefits in preventing cardiovascular diseases.

The main goal of this research is to investigate how O3 supplementation influences several key cardiovascular risk markers and overall vascular health. Specifically, the study will assess and analyze changes in cholesterol levels, triglycerides, uric acid, and blood glucose levels. Since inflammation plays a major role in heart disease, the study will examine how O3 affects inflammatory markers, including ferritin, high-sensitivity C-reactive protein (hsPCR), and the neutrophil-to-leukocyte ratio. These indicators help determine the level of systemic inflammation in the body. The study also aims to measure whether O3 supplementation improves vascular elasticity.

Apart from the primary cardiovascular effects, the study also aims to determine the tolerance levels of participants receiving O3 supplementation based on their cardiovascular profiles.

The study is based on the hypothesis that taking 2 grams of O3 daily for 12 weeks will lead to a significant reduction in triglyceride levels, lower inflammation markers, improved metabolic risk factors, and enhanced arterial elasticity, which can prevent or slow the progression of cardiovascular diseases. This hypothesis is supported by growing scientific evidence that suggests O3 fatty acids, particularly long-chain polyunsaturated fatty acids (DHA and EPA), have strong cardioprotective properties.

This is a clinical study that is planned in a prospective, interventional, randomized, placebo-controlled, and double-blind format. This means that participants will be randomly assigned to either the treatment group or the placebo group, and neither the participants nor the researchers will know who is receiving the actual treatment until the study ends.

This study is a pilot study, meaning it is a small-scale preliminary study designed to test the hypothesis before conducting a larger trial.

A total of 100 participants will be recruited. Participants will be randomly assigned into two groups: O3 group, receives omega-3 (O3) treatment; and control group, receives a placebo. The assignment will be 1:1 randomization, meaning each participant has an equal (50%) chance of receiving either the treatment or the placebo. The number of participants was chosen based on estimates that a 10% reduction in blood pressure measurements (mean arterial, brachial systolic, brachial diastolic, or central systolic) would be a meaningful outcome.

The duration of omega-3 intervention is based on previous research.

Enrollment: 100 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signature of informed consent to participate. Without situations that potentially cause their departure from the country or the possibilities of follow-up during the study.

Diagnosis of hypertriglyceridemia defined as mild 150-199 mg/ moderate 200-499 mg and severe more than 500 mg.

Diagnosis of controlled arterial hypertension (BP ≤140/90 mm Hg) with stable pharmacological treatment (definitions of the Argentine Consensus on HTA, 2018).

Women of childbearing age will be included only if they are under contraceptive treatment, adopted prior to the invitation to participate in the study (hormonal contraceptives (oral, injectable, implantable, etc., intrauterine devices).

Exclusion criteria

• Hypersensitivity to the active ingredient, or to soy, or allergy to fish. Liver failure. Pregnancy and breastfeeding. Active anticoagulant treatment. Women of childbearing age who do not use contraceptive methods prior to the invitation to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

O3 Group

Active Comparator group

Description:

2 grams/day of omega 3 capsules will be administered orally with food to optimize tolerance. (2 capsules). OMECAP 90 will be used (Registered trademark and approved by ANMAT). The capsules are provided free of charge by the manufacturer. It is recommended not to take on an empty stomach to improve tolerance. It comes in the form of capsules containing 1000 mg of omega 3 ethyl esters at 90%, gelatin 260 mg, glycerin 151 mg and purified water 39 mg.

Treatment:

Dietary Supplement: omega 3 ethyl esters at 90%

Control Group

Placebo Comparator group

Description:

Mygliol 812 will be used, a mixture of various medium chain fatty acids (6 to 12 carbon atoms) that are present in various vegetable oils and do not have significant adverse effects. A capsule with the same characteristics as the O3 capsule will be administered and the same administration will be carried out.

Treatment:

Dietary Supplement: Placebo