Effect of Omega 3 in Hypertensive Patients

NCT06840964 | Completed

• 1 other identifier: 20220325
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

hypertension; dyslipidemia; Triglycerides; omega-3 fatty acids

Outcome Measures

Primary Outcomes (15)

• Mean change in office systolic blood pressure from baseline

  Mean change in office Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office systolic blood pressure. Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.

  From enrollment to the end of treatment at 12 weeks

• Mean change in office diastolic blood pressure from baseline

  Mean change in office Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office diastolic blood pressure. Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.

  From enrollment to the end of treatment at 12 weeks

• Mean change in 24h and Daytime Ambulatory Systolic Arterial Blood Pressure from baseline

  Mean change in 24h and Daytime Ambulatory Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in systolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.

  From enrollment to the end of treatment at 12 weeks

• Mean change in 24h and Daytime Ambulatory Diastolic Arterial Blood Pressure from baseline

  Mean change in 24h and Daytime Ambulatory Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in diastolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.

  From enrollment to the end of treatment at 12 weeks

• Mean change in resting pulse wave velocity from baseline

  Measurement of pulse wave velocity (PWV) in meters per second. The calibrated and validated Mobil-O-Graph® portable monitor (IEM GmbH, Stolberg, Germany) will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch. All measurements will be performed on the left arm of the participant, at rest. Subjects will be instructed to be with empty bladder, not to drink coffee 60 minutes before gauging and alcoholic beverage in the last 24 hours.

  From enrollment to the end of treatment at 12 weeks

• Mean change in total cholesterol from baseline

  Mean change in cholesterol in Milligram/deciliter from baseline, it measures average changes in cholesterol.

  From enrollment to the end of treatment at 12 weeks

• Mean change in high density lipoprotein from baseline

  Mean change in high density lipoprotein (HDL) in Milligram/deciliter from baseline, it measures average changes in (HDL) cholesterol.

  From enrollment to the end of treatment at 12 weeks

• Mean change in triglycerides from baseline

  Mean change in triglycerides in Milligram/deciliter from baseline, it measures average changes in plasma triglycerides.

  From enrollment to the end of treatment at 12 weeks

• Mean change in fasting blood sugar from baseline

  Mean change in fasting blood sugar in Milligram/deciliter from baseline, it measures average changes in fasting blood sugar.

  From enrollment to the end of treatment at 12 weeks

• Mean change in high sensitive C reactive protein from baseline

  Mean change in high sensitive C reactive protein (Hs-CRP) in Milligram/liter, it measures average changes in high sensitive C reactive protein (Hs-CRP).

  From enrollment to the end of treatment at 12 weeks

• Mean change in serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase from baseline

  Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) in units per liter (U/L).

  From enrollment to the end of treatment at 12 weeks

• Mean change in serum alanine transaminase/Serum Glutamic Pyruvic Transaminase from baseline

  Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) in units per liter (U/L).

  From enrollment to the end of treatment at 12 weeks

• Mean change in fasting plasma insulin from baseline

  Fasting plasma insulin after fasting for 8-12 hours. Results are reported in micro International Units per milliliter (uIU/mL)

  From enrollment to the end of treatment at 12 weeks

• Mean change in serum ferritin from baseline

  Serum ferritin is measured in nanograms per milliliter (ng/mL)

  From enrollment to the end of treatment at 12 weeks

• Mean change in neutrophil-to-lymphocyte ratio from baseline

  The neutrophil-to-lymphocyte ratio (NLR) is a measurement of the number of neutrophils compared to the number of lymphocytes in a blood sample. It's calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. An automated cell counter with mixed technologies performs the calculation.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• Tolerability and safety

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

O3 Group

ACTIVE COMPARATOR

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.

Dietary Supplement: omega 3 ethyl esters at 90%

Control Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

omega 3 ethyl esters at 90% DIETARY_SUPPLEMENT

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

O3 Group

Placebo DIETARY_SUPPLEMENT

Mygliol 812

Control Group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Maria de la Salud, Argentina: lead
• Gador S.A.: collaborator

Study Sites (1)

Santa Maria de la Salud

San Isidro, Buenos Aires, 1642, Argentina

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Virginia C Kotliar, MD, MSc, PhD

  Santa Maria de la Salud. CONICET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 21, 2025
• Study Start: March 23, 2023
• Primary Completion: June 3, 2024
• Study Completion: August 30, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Unending
• Access Criteria: A proposal that describes planned analyses must be send by email.

Locations

AR (1)