Effect of Omega 3 in Hypertensive Patients

NCT ID: NCT06840964

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2024-08-30

Brief Summary

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.

Conditions

Hypertension; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

O3 Group

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.

Group Type: ACTIVE_COMPARATOR

omega 3 ethyl esters at 90%

Intervention Type: DIETARY_SUPPLEMENT

2 grams/day of omega 3 capsules will be administered orally, for 12 weeks

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Mygliol 812

Interventions

omega 3 ethyl esters at 90%

2 grams/day of omega 3 capsules will be administered orally, for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Mygliol 812

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gador S.A.

INDUSTRY

Sponsor Role: collaborator

Santa Maria de la Salud, Argentina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia C Kotliar, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Santa Maria de la Salud. CONICET

Locations

Santa Maria de la Salud

San Isidro, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

20220325

Identifier Type: -

Identifier Source: org_study_id