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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: MAG-EPA

• Registration Number: NCT03159507
• Lead Sponsor: SCF Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Study Start: 2017-10-02
• Status Verified: 2018-10
• Primary Completion: 2019-03-14
• Study Completion: 2019-03-14
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Omega-3 Index	8 weeks	Achievement of an omega-3 index of 8.

Secondary Outcome Measures

Name	Time	Method
Heart rate	8 weeks	Confirm the link between the optimal omega-3 index and heart rate (bpm)
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)
HDL-cholesterol	8 weeks	Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/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)
Diastolic blood pressure	8 weeks	Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)
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
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)
Alanine aminotransferase	8 weeks	Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L
LDL-cholesterol	8 weeks	Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/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)

Trial Locations

Locations (1)

SCF Pharma; 🇨🇦 Rimouski, Quebec, Canada