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Effect of Fish Oil Monoglycerides on the Omega-3 Index

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: NCT03735836
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Samuel Fortin, SCF Pharma

Study Description
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Brief Summary:
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA). Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first sample will be taken before the start of treatment and then every four (4) weeks during treatment. Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. Apart from the study treatment and collection of samples for the measurement of the omega-3 index, the only other interventions will be the measurement of body weight at screening and at the end of the study, pregnancy test for women at screening, questioning for demographic information and for the follow-up of the subject's health and concomitant medication intake.

Condition or disease Intervention/treatment Phase
Pharmacokinetic in Normal Population Other: MAG-EPA/MAG-DHA omega-3 oils Phase 4

Detailed Description:

Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. The study population will be men and women of 19 years and older, with no allergy or history of allergy to fish. Participants must not have taken omega-3 supplements in the last 60 days prior to study enrollment. Pregnant or lactating women will be excluded from the study.

The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period of treatment, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated monoglyceride (MAG) form of omega-3 fish oil that is better absorbed by the body compared to regular fish oil. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA).

Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first blood sample will be taken before the start of treatment and then at week four (4), eight (8), twelve (12), sixteen (16) and twenty (20). Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. The samples will all be taken by capillary puncture during visits at the clinic. A total of nine (9) visits may be done including the recruitment/screening/enrollment visit. Visit 1 could be done immediately after enrollment for a total of eight (8) visits instead of nine.

The screening tasks include pregnancy testing for women, measurement of the omega-3 index, body weight and height, recording of the baseline health status and concomitant treatment. Then, for visits 2 to 5, study treatment will be dispensed, returned and accounted, blood sample will be collected for the measurement of the omega-3 index, and the health status will be followed for any adverse event outcome.

Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well as the follow-up of the health status and concomitant medication intake.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized study with two parallel treatment arms.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 9, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MaxSimil 2 capsules daily
Subjects will receive two (2) capsules per day of MAG-EPA/MAG-DHA omega-3 oils for a total of 600mg of MAG-EPA and 260mg of MAG-DHA daily during 20 consecutive weeks of treatment.
 Other: MAG-EPA/MAG-DHA omega-3 oils
The monoglyceride (MAG) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are chemically modified fish oils that fall into the Natural Health products category in Canada.
Experimental: MaxSimil 3 capsules daily
Subjects will receive two (3) capsules per day of of MAG-EPA/MAG-DHA omega-3 oils for a total of 900mg of MAG-EPA and 390mg of MAG-DHA daily during 20 consecutive weeks of treatment.
 Other: MAG-EPA/MAG-DHA omega-3 oils
The monoglyceride (MAG) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are chemically modified fish oils that fall into the Natural Health products category in Canada.


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state. [ Time Frame: 12 months ]
    The objective of this pilot study is to collect preliminary bioavailability data for two different daily doses of MaxSimil at steady-state, that to say 600mg/260mg and 900mg/490mg daily of EPA/DHA. Blood samples will be taken by capillary puncture at specific time points during treatment and will be analysed to establish the omega-3 index (the fraction of EPA + DHA in the total fatty acids contained in red blood cells) which serves as bioavailability marker.


Eligibility Criteria
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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:

  1. Participant of at least 19 years old.
  2. Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form (ICF) duly read and signed by the latter.
  3. 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 coordinator of the study.
  4. Participant having no difficulty swallowing tablets or capsules.

Exclusion Criteria:

  1. Known allergy to fish or history of allergic reactions attributable to fish, or a compound similar to fish oil.
  2. Females who are pregnant or lactating, or has tested positive to a pregnancy test at screening.
  3. Participant who used omega-3 supplements within 60 days prior to Day 1 of the study.
  4. Participant who, in the opinion of the research coordinator, may not be able to comply with the requirements of the protocol
Contacts and Locations
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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): NCT03735836


Locations
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Canada, Quebec
Clinique Gestion Santé de la Baie
Maria, Quebec, Canada, G0C 1Y0
Clinique GSM du Littoral
Pointe-au-Père, Quebec, Canada, G0K 1P0
Sponsors and Collaborators
Samuel Fortin
More Information
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Responsible Party: Samuel Fortin, Principal Investigator, SCF Pharma
ClinicalTrials.gov Identifier: NCT03735836    
Other Study ID Numbers: IO3-02
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
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
Product Manufactured in and Exported from the U.S.: No