Clinical trial NCT03735836: Effect of Fish Oil Monoglycerides on the Omega-3 Index
Official title: Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacokinetic in Normal Population
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study with two parallel treatment arms.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maria
country: Canada
facility: Clinique Gestion Santé de la Baie
state: Quebec
city: Pointe-au-Père
country: Canada
facility: Clinique GSM du Littoral
state: Quebec
Study officials:
References: