search
Back to results

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

Primary Purpose

Cardiovascular Risk Factor, Covid19

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
300 mg of omega3-FA
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factor

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mahmoud S Abu-Samak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

n-3FA group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

serum ACE levels
Angiotensin converting enzyme levels pg/mL
serum ACE2 levels
Angiotensin converting enzyme-2 levels

Secondary Outcome Measures

Lipid profile mg/dL
TC,LDL,HDL,TG

Full Information

First Posted
December 5, 2020
Last Updated
February 23, 2022
Sponsor
Applied Science Private University
search

1. Study Identification

Unique Protocol Identification Number
NCT04658433
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
n-3FA group
Arm Type
Experimental
Arm Description
Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 8 weeks.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
300 mg of omega3-FA
Intervention Description
The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
Primary Outcome Measure Information:
Title
serum ACE levels
Description
Angiotensin converting enzyme levels pg/mL
Time Frame
10 weeks
Title
serum ACE2 levels
Description
Angiotensin converting enzyme-2 levels
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Lipid profile mg/dL
Description
TC,LDL,HDL,TG
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara M Daboul, MSC
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud S Abu-Samak
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs