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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: MAG-EPA

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Omega-3 Index	Achievement of an omega-3 index of 8.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	8 weeks
Heart rate	Confirm the link between the optimal omega-3 index and heart rate (bpm)	8 weeks
Total Cholesterol	Confirm the link between the optimal omega-3 index and total cholesterol (in mmol/L)	8 weeks
Triglycerides	Confirm the link between the optimal omega-3 index and triglycerides level (in mmol/L)	8 weeks
HDL-cholesterol	Confirm the link between the optimal omega-3 index and HDL-cholesterol (in mmol/L)	8 weeks
LDL-cholesterol	Confirm the link between the optimal omega-3 index and LDL-cholesterol (in mmol/L)	8 weeks
Alanine aminotransferase	Confirm the link between the optimal omega-3 index and alanine aminotransferase (in U/L	8 weeks
Aspartate aminotransferase	Confirm the link between the optimal omega-3 index and aspartate aminotransferase (in U/L)	8 weeks
Bilirubin	Confirm the link between the optimal omega-3 index and Bilirubin (in µmol/L)	8 weeks
Albumin	Confirm the link between the optimal omega-3 index and Albumin (in g/L)	8 weeks
C-reactive protein	Confirm the link between the optimal omega-3 index and C-reactive protein (in mg/L)	8 weeks
Apolipoprotein B	Confirm the link between the optimal omega-3 index and Apolipoprotin B (in mmol/L)	8 weeks
Erythrocyte sedimentation rate	Confirm the link between the optimal omega-3 index and the erythrocyte sedimentation rate (in min)	8 weeks
Systolic blood pressure	Confirm the link between the optimal omega-3 index and the systolic blood pressure (in mm Hg)	8 weeks
Diastolic blood pressure	Confirm the link between the optimal omega-3 index and the diastolic blood pressure (in mm Hg)	8 weeks

Collaborators and Investigators

• Sponsor: SCF Pharma
• Collaborators: Université du Québec à Rimouski
• Investigators: Study Director: Anne-Julie Landry, MSc, SCF Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Omega-3 Index; Cellular metabolism; EPA Monoglyceride
• Other Study ID Numbers: IO3-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No