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


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Verified May 2017 by SCF Pharma

Sponsor:

Collaborator:

Université du Québec à Rimouski

Information provided by (Responsible Party):

SCF Pharma

ClinicalTrials.gov Identifier:

NCT03159507

First received: May 17, 2017

Last updated: May 17, 2017

Last verified: May 2017

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

Healthy Dietary Supplement: MAG-EPA Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

Prospective, single arm trial where each participant receives a personalized dose

Masking: No masking
Primary Purpose: Prevention

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

Primary Outcome Measures:

Secondary Outcome Measures:

  • Cellular metabolism [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]

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

  • Total Cholesterol [ Time Frame: 8 weeks ]

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

  • Triglycerides [ Time Frame: 8 weeks ]

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

  • HDL-cholesterol [ Time Frame: 8 weeks ]

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

  • LDL-cholesterol [ Time Frame: 8 weeks ]

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

  • Alanine aminotransferase [ Time Frame: 8 weeks ]

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

  • Aspartate aminotransferase [ Time Frame: 8 weeks ]

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

  • Bilirubin [ Time Frame: 8 weeks ]

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

  • Albumin [ Time Frame: 8 weeks ]

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

  • C-reactive protein [ Time Frame: 8 weeks ]

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

  • Apolipoprotein B [ Time Frame: 8 weeks ]

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

  • Erythrocyte sedimentation rate [ Time Frame: 8 weeks ]

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

  • Systolic blood pressure [ Time Frame: 8 weeks ]

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

  • Diastolic blood pressure [ Time Frame: 8 weeks ]

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

Estimated Enrollment: 16
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participant aged 18 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03159507

SCF Pharma
Rimouski, Quebec, Canada, G5M 1J5
Contact: Samuel Fortin, PhD    514 317-9347    sfortin@scfpharma.com   

SCF Pharma

Université du Québec à Rimouski

Study Director: Anne-Julie Landry, MSc SCF Pharma

Responsible Party: SCF Pharma
ClinicalTrials.gov Identifier: NCT03159507     History of Changes
Other Study ID Numbers: IO3-01
Study First Received: May 17, 2017
Last Updated: May 17, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 18, 2017