Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil
| Registry | NCT03159507 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; na, single group, masking: none, basic science |
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| Enrollment | 16 (Actual) |
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| Sponsor | SCF Pharma (Industry); collaborators: Université du Québec à Rimouski |
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| Conditions | Healthy |
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| Interventions | MAG-EPA (Dietary supplement) |
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| Dates | start 2017-10-02, primary completion 2019-03-14, completion 2019-03-14, first posted 2017-05-18, last updated 2019-04-04 |
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| Locations | 1 site in Canada |
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-Summary
Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| MAG-EPA | Experimental | Dietary Supplement: MAG-EPA | MAG-EPA softgel (500mg), daily dose between 1g and 3.5g |
- MAG-EPA (Dietary 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.
+Outcome measures
Primary outcomes
- Omega-3 Index [8 weeks]: Achievement of an omega-3 index of 8.
Secondary outcomes
- Cellular metabolism [8 weeks]: 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
- Quality of life [8 weeks]: 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)
- Heart rate [8 weeks]: Confirm the link between the optimal omega-3 index and heart rate (bpm)
- Total Cholesterol [8 weeks]: Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L)
- Triglycerides [8 weeks]: Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L)
- HDL-cholesterol [8 weeks]: Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L)
- LDL-cholesterol [8 weeks]: Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L)
- Alanine aminotransferase [8 weeks]: Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L
- Aspartate aminotransferase [8 weeks]: Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L)
- Bilirubin [8 weeks]: Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L)
- Albumin [8 weeks]: Confirm the link between the optimal omega-3 index and Albumin (in g/L)
- C-reactive protein [8 weeks]: Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L)
- Apolipoprotein B [8 weeks]: Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L)
- Erythrocyte sedimentation rate [8 weeks]: Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min)
- Systolic blood pressure [8 weeks]: Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg)
- Diastolic blood pressure [8 weeks]: Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)
+Eligibility
Sex: All, ages: 19 Years to any, accepts healthy volunteers
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:
* Allergy known to fish
* Pregnant women who breast-feed or test positive for pregnancy
+Locations (1)
| Facility | City | Country | Status |
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| SCF Pharma | Rimouski, Quebec | Canada | |
+Investigators