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

NCT04658433 | Completed

• 1 other identifier: 2020-PHA-22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 \[5,9\].

Conditions

Cardiovascular Risk Factor; Covid19

Outcome Measures

Primary Outcomes (2)

• serum ACE levels

  Angiotensin converting enzyme levels pg/mL

  10 weeks

• serum ACE2 levels

  Angiotensin converting enzyme-2 levels

  10 weeks

Secondary Outcomes (1)

• Lipid profile mg/dL

  10 weeks

Study Arms (2)

n-3FA group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

300 mg of omega3-FA DIETARY_SUPPLEMENT

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

n-3FA group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (1)

Mahmoud S Abu-Samak

Amman, Jordan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mahmoud S Abu-Samak, PhD

  Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

  STUDY CHAIR

• Sara M Daboul, MSC

  Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 8, 2020
• Study Start: March 5, 2021
• Primary Completion: December 20, 2021
• Study Completion: February 10, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

JO (1)