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CompletedNCT03159507Updated Apr 4, 2019

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

A Phase 4 interventional study of MAG-EPA in Healthy, sponsored by SCF Pharma. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by SCF Pharma · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Omega-3 Index
  • Cellular metabolism
  • EPA Monoglyceride
  • Quality of life
03

In context

Lead sponsor

SCF Pharma is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Allergy known to fish
  • Pregnant women who breast-feed or test positive for pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    MAG-EPA

    MAG-EPA softgel (500mg), daily dose between 1g and 3.5g

    Dietary Supplement: MAG-EPA

Interventions

  • Dietary supplementMAG-EPA

    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.

06

What researchers measure

Primary outcomes

  1. Omega-3 Index

    Achievement of an omega-3 index of 8.

    Time frame: 8 weeks

Secondary outcomes

  1. 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

    Time frame: 8 weeks

  2. 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)

    Time frame: 8 weeks

  3. Heart rate

    Confirm the link between the optimal omega-3 index and heart rate (bpm)

    Time frame: 8 weeks

  4. Total Cholesterol

    Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L)

    Time frame: 8 weeks

  5. Triglycerides

    Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L)

    Time frame: 8 weeks

  6. HDL-cholesterol

    Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L)

    Time frame: 8 weeks

  7. LDL-cholesterol

    Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L)

    Time frame: 8 weeks

  8. Alanine aminotransferase

    Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L

    Time frame: 8 weeks

  9. Aspartate aminotransferase

    Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L)

    Time frame: 8 weeks

  10. Bilirubin

    Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L)

    Time frame: 8 weeks

  11. Albumin

    Confirm the link between the optimal omega-3 index and Albumin (in g/L)

    Time frame: 8 weeks

  12. C-reactive protein

    Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L)

    Time frame: 8 weeks

  13. Apolipoprotein B

    Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L)

    Time frame: 8 weeks

  14. Erythrocyte sedimentation rate

    Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min)

    Time frame: 8 weeks

  15. Systolic blood pressure

    Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg)

    Time frame: 8 weeks

  16. Diastolic blood pressure

    Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)

    Time frame: 8 weeks

07

Study locations

1 site
  • SCF Pharma
    Rimouski, Quebec G5M 1J5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Mar 2019, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2017
First posted
May 18, 2017
StartActual
Oct 2, 2017
Primary completionActual
Mar 14, 2019
CompletionActual
Mar 14, 2019
Last update
Apr 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03159507
Lead sponsor
SCF Pharma
Collaborators
Université du Québec à Rimouski
Responsible party
Sponsor
First posted
May 18, 2017
Start date
Oct 2, 2017
Primary completion
Mar 14, 2019
Completion
Mar 14, 2019
Last update
Apr 4, 2019

Study contacts

Anne-Julie Landry, MSc
study director · SCF Pharma

Oversight

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

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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