NCT03159507

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Oct 2017

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2019

Completed
Last Updated

April 4, 2019

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

May 17, 2017

Last Update Submit

April 2, 2019

Conditions

Healthy

Keywords

Omega-3 IndexCellular metabolismEPA MonoglycerideQuality of life

Outcome Measures

Primary Outcomes (1)

  • Omega-3 Index

    Achievement of an omega-3 index of 8.

    8 weeks

Secondary Outcomes (16)

  • Cellular metabolism

    8 weeks

  • Quality of life

    8 weeks

  • Heart rate

    8 weeks

  • Total Cholesterol

    8 weeks

  • Triglycerides

    8 weeks

  • +11 more secondary outcomes

Study Arms (1)

MAG-EPA

EXPERIMENTAL

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

Dietary Supplement: MAG-EPA

Interventions

MAG-EPADIETARY_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.

MAG-EPA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCF Pharma

Rimouski, Quebec, G5M 1J5, Canada

Location

MeSH Terms

Interventions

1-eicosapentaenoylglycerol

Study Officials

  • Anne-Julie Landry, MSc

    SCF Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Prospective, single arm trial where each participant receives a personalized dose
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

October 2, 2017

Primary Completion

March 14, 2019

Study Completion

March 14, 2019

Last Updated

April 4, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)