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

• Sponsor: SCF Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03159507
• Collaborator: Université du Québec à Rimouski (Other)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: MAG-EPA	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, single arm trial where each participant receives a personalized doseProspective, single arm trial where each participant receives a personalized dose
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Oct 2, 2017
• Actual Primary Completion Date: Mar 14, 2019
• Actual Study Completion Date: Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAG-EPA MAG-EPA softgel (500mg), daily dose between 1g and 3.5g	Dietary Supplement: MAG-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.

Outcome Measures

Primary Outcome Measures

1. Omega-3 Index [8 weeks]

   Achievement of an omega-3 index of 8.

Secondary Outcome Measures

1. 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

2. 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)

3. Heart rate [8 weeks]

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

4. Total Cholesterol [8 weeks]

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

5. Triglycerides [8 weeks]

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

6. HDL-cholesterol [8 weeks]

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

7. LDL-cholesterol [8 weeks]

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

8. Alanine aminotransferase [8 weeks]

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

9. Aspartate aminotransferase [8 weeks]

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

10. Bilirubin [8 weeks]

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

11. Albumin [8 weeks]

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

12. C-reactive protein [8 weeks]

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

13. Apolipoprotein B [8 weeks]

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

14. Erythrocyte sedimentation rate [8 weeks]

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

15. Systolic blood pressure [8 weeks]

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

16. Diastolic blood pressure [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SCF Pharma	Rimouski	Quebec	Canada	G5M 1J5

Sponsors and Collaborators

• SCF Pharma
• Université du Québec à Rimouski

Investigators

• Study Director: Anne-Julie Landry, MSc, SCF Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SCF Pharma
• ClinicalTrials.gov Identifier: NCT03159507
• Other Study ID Numbers: IO3-01
• First Posted: May 18, 2017
• Last Update Posted: Apr 4, 2019
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SCF Pharma: Omega-3 Index; Cellular metabolism; EPA Monoglyceride; Quality of life

Study Results

No Results Posted as of Apr 4, 2019