Clinical trial NCT06840964: Effect of Omega 3 in Hypertensive Patients
Official title: Analysis of the Effect of Acidified Omega 3 Esters (DHA+EPA) in Hypertensive Patients With Increased Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Dyslipidemia
Keywords: hypertension
dyslipidemia
Triglycerides
omega-3 fatty acids
Lead sponsor: Santa Maria de la Salud, Argentina
Sponsor class: OTHER
Collaborators: name: Gador S.A.
First posted: 2025-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean change in office systolic blood pressure from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in office diastolic blood pressure from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in 24h and Daytime Ambulatory Systolic Arterial Blood Pressure from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in 24h and Daytime Ambulatory Diastolic Arterial Blood Pressure from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in resting pulse wave velocity from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in total cholesterol from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in high density lipoprotein from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in triglycerides from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in fasting blood sugar from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in high sensitive C reactive protein from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in serum alanine transaminase/Serum Glutamic Pyruvic Transaminase from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in fasting plasma insulin from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in serum ferritin from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mean change in neutrophil-to-lymphocyte ratio from baseline
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Tolerability and safety
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: San Isidro
country: Argentina
facility: Santa Maria de la Salud
state: Buenos Aires
Study officials:
affiliation: Santa Maria de la Salud. CONICET
name: Virginia C Kotliar, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: