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

NCT04159532 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-29

No results posted yet for this study

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.

Conditions

  • Healthy Adults

Interventions

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

Sponsors & Collaborators

  • SCF Pharma

    lead INDUSTRY

Principal Investigators

  • Samuel Fortin, PhD · SCF Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2021-02-25
Completion
2021-02-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159532 on ClinicalTrials.gov