HealthyPhase 4NCT03159507

Effect of Omega-3 Index on Cellular Metabolism and Quality of Life

A Phase 4 study testing MAG-EPA in people with Healthy, run by SCF Pharma at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form). Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MAG-EPA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteCanada
Study dates: 2 Oct 2017to 14 Mar 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant aged 19 or over
Available for the entire duration of the study and willing to participate on the basis of the information provided in the FIU duly read and signed.

Who cannot join

Allergy known to fish
Pregnant women who breast-feed or test positive for pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site

SCF Pharma
Rimouski, Quebec, G5M 1J5

Other trials in Canada

About this study

Official title: Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil

Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).

Conditions: Healthy
Being tested: MAG-EPA
Keywords: Omega-3 Index, Cellular metabolism, EPA Monoglyceride, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAG-EPADietary supplement
Based on the result of the participant's Omega-3 index obtained from the blood sampling of visit 1, the daily dose of MAG-EPA will be adjusted to obtain an Omega-3 Index of 8.

Study groups in NCT03159507
Study group	Role	What they receive
MAG-EPA	Experimental	MAG-EPA softgel (500mg), daily dose between 1g and 3.5g Receives: Dietary Supplement: MAG-EPA

What is being measured

The primary outcome is the main question the study is designed to answer.

Omega-3 Index
Achievement of an omega-3 index of 8.
Measured: 8 weeks

Secondary outcomes (16)

Cellular metabolism
To determine whether the achievement of the optimal level of the omega-3 index results in an improvement in the white blood cell energy metabolism
Measured: 8 weeks
Quality of life
Determine whether the achievement of the optimal level of the Omega-3 index results in an improvement in quality of life (according to Form SF-36)
Measured: 8 weeks
Heart rate
Confirm the link between the optimal omega-3 index and heart rate (bpm)
Measured: 8 weeks
Total Cholesterol
Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L)
Measured: 8 weeks
Triglycerides
Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L)
Measured: 8 weeks
HDL-cholesterol
Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L)
Measured: 8 weeks
LDL-cholesterol
Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L)
Measured: 8 weeks
Alanine aminotransferase
Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L
Measured: 8 weeks
Aspartate aminotransferase
Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L)
Measured: 8 weeks
Bilirubin
Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L)
Measured: 8 weeks
Albumin
Confirm the link between the optimal omega-3 index and Albumin (in g/L)
Measured: 8 weeks
C-reactive protein
Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L)
Measured: 8 weeks
Apolipoprotein B
Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L)
Measured: 8 weeks
Erythrocyte sedimentation rate
Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min)
Measured: 8 weeks
Systolic blood pressure
Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg)
Measured: 8 weeks
Diastolic blood pressure
Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 201714 Mar 2019

First posted18 May 2017
Study start2 Oct 2017
Primary completion14 Mar 2019
Study completion14 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, single arm trial where each participant receives a personalized dose
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03159507
Sponsor's protocol ID: IO3-01
Status last verified: Oct 2018
First submitted: 17 May 2017
Last updated: 4 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil
ClinicalTrials.gov ID: NCT03159507
Acronym / sponsor ID: IO3-01
Conditions: Healthy
Keywords: Omega-3 Index, Cellular metabolism, EPA Monoglyceride, Quality of life
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: SCF PharmaIndustry (pharma, biotech, devices)
Collaborators: Université du Québec à Rimouski
Study start: 2 Oct 2017 (actual)
Primary completion: 14 Mar 2019 (actual)
Study completion: 14 Mar 2019 (actual)
First posted: 18 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, single arm trial where each participant receives a personalized dose

Arm	Type	Receives
MAG-EPA	Experimental	Dietary Supplement: MAG-EPAMAG-EPA softgel (500mg), daily dose between 1g and 3.5g

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant aged 19 or over
Available for the entire duration of the study and willing to participate on the basis of the information provided in the FIU duly read and signed.

Key exclusion criteria (2 listed)

Allergy known to fish
Pregnant women who breast-feed or test positive for pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAG-EPABased on the result of the participant's Omega-3 index obtained from the blood sampling of visit 1, the daily dose of MAG-EPA will be adjusted to obtain an Omega-3 Index of 8.	Dietary supplement	MAG-EPA

Primary outcome

Omega-3 Index
Time frame: 8 weeks
Achievement of an omega-3 index of 8.

16 secondary outcomes

Cellular metabolism
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Heart rate
Time frame: 8 weeks
Total Cholesterol
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
HDL-cholesterol
Time frame: 8 weeks
LDL-cholesterol
Time frame: 8 weeks
Alanine aminotransferase
Time frame: 8 weeks
Aspartate aminotransferase
Time frame: 8 weeks
Bilirubin
Time frame: 8 weeks
Albumin
Time frame: 8 weeks
C-reactive protein
Time frame: 8 weeks
Apolipoprotein B
Time frame: 8 weeks
Erythrocyte sedimentation rate
Time frame: 8 weeks
Systolic blood pressure
Time frame: 8 weeks
Diastolic blood pressure
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne-Julie Landry, MSc study director

SCF Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MAG-EPA in people with Healthy, run by SCF Pharma at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Omega-3 Index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03159507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.