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CompletedNCT04658433Updated Feb 24, 2022

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

An interventional study of 300 mg of omega3-FA in Cardiovascular Risk Factor and Covid19, sponsored by Applied Science Private University. Completed at 1 site in Jordan. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Applied Science Private University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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].

02

Conditions studied

  • Cardiovascular Risk Factor
  • Covid19

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03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 4,175 interventional studies indexed under COVID-19.

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Lead sponsor

Applied Science Private University is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    n-3FA group

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

    Dietary Supplement: 300 mg of omega3-FA

  • No intervention
    Control group

Interventions

  • Dietary supplement300 mg of omega3-FA

    The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.

06

What researchers measure

Primary outcomes

  1. serum ACE levels

    Angiotensin converting enzyme levels pg/mL

    Time frame: 10 weeks

  2. serum ACE2 levels

    Angiotensin converting enzyme-2 levels

    Time frame: 10 weeks

Secondary outcomes

  1. Lipid profile mg/dL

    TC,LDL,HDL,TG

    Time frame: 10 weeks

07

Study locations

1 site
  • Mahmoud S Abu-Samak
    Amman, Jordan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04658433
Lead sponsor
Applied Science Private University
Responsible party
Mahmoud Suleiman Abu-Samak (Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University) — Principal investigator
First posted
Dec 8, 2020
Start date
Mar 5, 2021
Primary completion
Dec 20, 2021
Completion
Feb 10, 2022
Last update
Feb 24, 2022

Study contacts

Mahmoud S Abu-Samak, PhD
study chair · Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Sara M Daboul, MSC
principal investigator · Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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