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Comparative Study of Three Different Formulations of Omega-3 (EPA+DHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159532
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
SCF Pharma

Brief Summary:
This pilot study aims at comparing the bioavailability of three different formulations of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG). Thirty six (36) subjects will be divided in three groups of twelve subjects each equally divided in two study sites. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: MAG-EPA/MAG-DHA Dietary Supplement: TG-EPA/TG-DHA Dietary Supplement: EE-EPA/EE-DHA Phase 4

Detailed Description:
This pilot study aims at comparing the bioavailability of three different formulations of a combination of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a standardized proportion of 460:200. The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG) versions of these fatty acids. The formulations are prepared in a way to be similar in proportion of EPA/DHA, in dose and in appearance. Thirty six (36) subjects will be divided in three groups of twelve subjects each, equally divided in two study sites. The study will be randomized and double blinded. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment. After recruitment, subjects will be seen in clinic every four weeks for a total of four (4) study visits during which a blood sample will be taken for analysis of the omega-3 index, the investigational product will be returned and dispensed and finally, adverse events will be noted and followed. Treatment will be self-administered by subjects at home. They will be asked to keep a journal of adverse events, concomitant medication and to note every missed dose as well as significant changes in life habits (smoking, alcohol, sports, food diet and natural health products intake).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, 3-arms parallel randomized study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded. Only the sponsor will have access to the randomisation list. No one at the sites will have access to the list.
Primary Purpose: Basic Science
Official Title: Comparative Bioavailability Study of Monoglyceride (MAG) Versus Triglyceride (TG) Versus Ethyl Ester (EE) Formulations of Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) Acids. Pilot Study (IO3-03)
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Monoglyceride (MAG)
Group A will receive the omega-3 fatty acids in monoglyceride formulation (MAG). Subjects will receive 1.5g per day of MAG-EPA/MAG-DHA in a proportion of 460:200 for 12 consecutive weeks.
Dietary Supplement: MAG-EPA/MAG-DHA
monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Active Comparator: Triglyceride (TG)
Group B will receive the omega-3 fatty acids in triglyceride formulation (TG). Subjects will receive 1.5g per day of TG-EPA/TG-DHA in a proportion of 460:200 for 12 consecutive weeks.
Dietary Supplement: TG-EPA/TG-DHA
Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Active Comparator: Ethyl Ester(EE)
Group C will receive the omega-3 fatty acids in Ethyl ester formulation (EE). Subjects will receive 1.5g per day of EE-EPA/EE-DHA in a proportion of 460:200 for 12 consecutive weeks.
Dietary Supplement: EE-EPA/EE-DHA
Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200




Primary Outcome Measures :
  1. Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study. [ Time Frame: 12 weeks per subject ]
    The Omega-3 index (ratio of EPA + DHA content on total fatty acids in red blood cells) will be measured throughout the study (at baseline and every four weeks afterwards) for each subjects. The average value in canadian population is 4.5%, however, for an optimized health, the desired index should be between 8 and 12% of omega-3 in cell membranes. The average omega-3 index curves obtained for each group will be compared to determine which formulation offers the best absorption of omega-3 in the organism.


Secondary Outcome Measures :
  1. Incidence of adverse events in subjects treated with EPA +DHA [ Time Frame: 16 weeks per subject ]
    Subjects will be questioned about any changes in their health status throughout the study, and for the 30 days following the end of treatment. All adverse events will recorded and evaluated for severity, causality and expectedness. All serious adverse events will be reported as required.

  2. Compilation of life habits & demographic information [ Time Frame: 12 weeks per subject ]
    Demographic information and life habits will be recorded at screening as to draw a portrait of the subjects baseline status. A follow-up of life habits at every visit will be done afterwards as a way to control any possible bias in outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants of at least 19 years of age.
  • Availability for the entire duration of the study, willingness to participate as evidenced by the informed consent form duly read and signed by the participant.
  • Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, to understand and observe the instructions of the physician or delegates.
  • Participant having no difficulty swallowing tablets or capsules.

Exclusion Criteria:

  • Known allergy or intolerance to fish or history of allergic reaction attributable to fish or to a compound similar to fish oil.
  • Females who are pregnant according to the qualitative pregnancy test or who are lactating.
  • Participants who took omega-3 supplements in the previous 60 days before day 1 of the study.
  • Difficulty to draw blood by capillary puncture at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159532


Locations
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Canada, Quebec
SCF pharma
Rimouski, Quebec, Canada, G0K 1P0
Sponsors and Collaborators
SCF Pharma
Investigators
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Principal Investigator: Samuel Fortin, PhD SCF Pharma
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Responsible Party: SCF Pharma
ClinicalTrials.gov Identifier: NCT04159532    
Other Study ID Numbers: IO3-03
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No