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Completed

NCT Number: NCT03159507

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

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

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SCF Pharma

Rimouski, Quebec, G5M 1J5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAG-EPA

Dietary 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.

Primary outcomes

  1. Omega-3 Index

    Time frame: 8 weeks

    Achievement of an omega-3 index of 8.

Secondary outcomes

  1. 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

  2. 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)

  3. Heart rate

    Time frame: 8 weeks

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

  4. Total Cholesterol

    Time frame: 8 weeks

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

  5. Triglycerides

    Time frame: 8 weeks

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

  6. HDL-cholesterol

    Time frame: 8 weeks

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

  7. LDL-cholesterol

    Time frame: 8 weeks

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

  8. Alanine aminotransferase

    Time frame: 8 weeks

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

  9. Aspartate aminotransferase

    Time frame: 8 weeks

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

  10. Bilirubin

    Time frame: 8 weeks

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

  11. Albumin

    Time frame: 8 weeks

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

  12. C-reactive protein

    Time frame: 8 weeks

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

  13. Apolipoprotein B

    Time frame: 8 weeks

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

  14. Erythrocyte sedimentation rate

    Time frame: 8 weeks

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

  15. Systolic blood pressure

    Time frame: 8 weeks

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

  16. Diastolic blood pressure

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

SCF Pharma

Industry

Collaborators

  • Université du Québec à Rimouski

Registry information

Official study title

Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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