Comparative Study of Three Different Formulations of Omega-3 (EPA+DHA)
|ClinicalTrials.gov Identifier: NCT04159532|
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : March 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adults||Dietary Supplement: MAG-EPA/MAG-DHA Dietary Supplement: TG-EPA/TG-DHA Dietary Supplement: EE-EPA/EE-DHA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, 3-arms parallel randomized study.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blinded. Only the sponsor will have access to the randomisation list. No one at the sites will have access to the list.|
|Primary Purpose:||Basic Science|
|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)|
|Actual Study Start Date :||December 18, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Monoglyceride (MAG)
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.
Dietary Supplement: MAG-EPA/MAG-DHA
monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
Active Comparator: Triglyceride (TG)
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.
Dietary Supplement: TG-EPA/TG-DHA
Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
Active Comparator: Ethyl Ester(EE)
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.
Dietary Supplement: EE-EPA/EE-DHA
Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
- Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study. [ Time Frame: 12 weeks per subject ]The Omega-3 index (ratio of EPA + DHA content on total fatty acids in red blood cells) will be measured throughout the study (at baseline and every four weeks afterwards) for each subjects. The average value in canadian population is 4.5%, however, for an optimized health, the desired index should be between 8 and 12% of omega-3 in cell membranes. The average omega-3 index curves obtained for each group will be compared to determine which formulation offers the best absorption of omega-3 in the organism.
- Incidence of adverse events in subjects treated with EPA +DHA [ Time Frame: 16 weeks per subject ]Subjects will be questioned about any changes in their health status throughout the study, and for the 30 days following the end of treatment. All adverse events will recorded and evaluated for severity, causality and expectedness. All serious adverse events will be reported as required.
- Compilation of life habits & demographic information [ Time Frame: 12 weeks per subject ]Demographic information and life habits will be recorded at screening as to draw a portrait of the subjects baseline status. A follow-up of life habits at every visit will be done afterwards as a way to control any possible bias in outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159532
|Rimouski, Quebec, Canada, G0K 1P0|
|Principal Investigator:||Samuel Fortin, PhD||SCF Pharma|