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

SCF Pharma

Status and phase: Completed; Phase 4

Conditions: Healthy Adults

Treatments: Dietary Supplement: EE-EPA/EE-DHA; Dietary Supplement: MAG-EPA/MAG-DHA; Dietary Supplement: TG-EPA/TG-DHA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159532

IO3-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

Monoglyceride (MAG)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MAG-EPA/MAG-DHA

Triglyceride (TG)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: TG-EPA/TG-DHA

Ethyl Ester(EE)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: EE-EPA/EE-DHA