NCT04159532

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: SCF Pharma · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MAG-EPA/MAG-DHA	monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
DIETARY_SUPPLEMENT	TG-EPA/TG-DHA	Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
DIETARY_SUPPLEMENT	EE-EPA/EE-DHA	Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Timeline

• Start date: 2019-12-18
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2019-11-12
• Last updated: 2021-04-29

Locations

1 site across 1 country: Canada