Clinical trial NCT04159532: Comparative Study of Three Different Formulations of Omega-3 (EPA+DHA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Adults
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, 3-arms parallel randomized study.
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility 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.

Primary outcomes:
measure: Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study.
timeFrame: 12 weeks per subject
Secondary outcomes:
measure: Incidence of adverse events in subjects treated with EPA +DHA
timeFrame: 16 weeks per subject
measure: Compilation of life habits & demographic information
timeFrame: 12 weeks per subject
Other outcomes:
Locations:
city: Rimouski
country: Canada
facility: SCF pharma
state: Quebec
Study officials:
affiliation: SCF Pharma
name: Samuel Fortin, PhD
role: PRINCIPAL_INVESTIGATOR
References: