The Effect of Omega -3 Supplements on the Serum Levels of ACE/ACE2 Ratio as a Potential Key in Cardiovascular Disease and COVID-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Covid19
• Interventions: Dietary Supplement: 300 mg of omega3-FA

• Registration Number: NCT04658433
• Lead Sponsor: Applied Science Private University

Brief Summary

The Renin-Angiotensin-Aldosterone System (RAAS) is involved in blood pressure regulation and electrolyte balance. Angiotensin-converting enzyme (ACE) is a critical regulator of RAAS by cleaving angiotensin (Ang1) to Angiotensin2 (Ang2), which is the most powerful biologically active product of RAAS \[1\]. In the same context, angiotensin-converting enzyme 2 (ACE2) converts Ang2 to Ang (1-7), which is a vasodilator, antithrombotic, and antihypertrophic peptide \[2\]. ACE2 which is found in many tissues \[3\] has opposite effects to ACE on the heart, kidneys, and lungs \[4\]. Many pathological conditions, in particular cardiovascular disease (CVD), have shown a link between a disturbance in ACE/ACE2 ratio and the downregulation of ACE2 levels \[5\]. Also, ACE/ACE2 has been reported to be higher in moderate to severe chronic heart failure \[6\] as well as systolic blood pressure \[7\]. Recently, an elevated ACE/ACE2 ratio is linked to Coronavirus disease 2019 (COVID-19). SARS-COV2 enters target cells by binding of the spike protein to ACE2 and a specific transmembrane serine protease 2 (TMPRSS2) for the spike (S) protein priming, which also leads to downregulation of ACE2 \[8\]. Down-regulation of ACE2 caused by Coronavirus may have a potential role in the pathogenesis of COVID-19 infection. Accordingly, people with a higher ACE/ACE2 ratio may be more at increased risk of worse Covid-19 consequences \[9\].

On the other hand, omega-3 fatty acids could decrease CVD risk by their anti-inflammatory anti-thrombotic function \[10\]. A meta-analysis comprising 15,806 patients, showed that omega-3 fatty acids associated with a 30% reduction in fatal myocardial infarction and sudden death, in addition to a 20% reduction in overall mortality \[11\]. To the best of our knowledge, no clinical trials have evaluated the effect of omega-3 supplementation on serum ACE/ACE2 ratio which is recently ascribed as a potential key in 2019 Covid-19 as well as CVD \[5,9\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Study Start: 2021-03-05
• Primary Completion: 2021-12-20
• Status Verified: 2022-02
• Study Completion: 2022-02-10
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inclusion criteria included males and females in the age range of 35-65 years without a medical diagnosis of COVID-19 infection.

Exclusion Criteria

• Any subject with any chronic disease such as CVD, diabetes, or immune problems, including autoimmune diseases, chronic or severe infections was excluded.
• Pregnant, breastfeeding, and females using hormonal contraceptives were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n-3FA group	300 mg of omega3-FA	Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 8 weeks.

Primary Outcome Measures

Name	Time	Method
serum ACE2 levels	10 weeks	Angiotensin converting enzyme-2 levels
serum ACE levels	10 weeks	Angiotensin converting enzyme levels pg/mL

Secondary Outcome Measures

Name	Time	Method
Lipid profile mg/dL	10 weeks	TC,LDL,HDL,TG

Trial Locations

Locations (1)

Mahmoud S Abu-Samak; 🇯🇴 Amman, Jordan