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

NCT04159532 | Completed Phase 4

• 1 other identifier: IO3-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study.

  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.

  12 weeks per subject

Secondary Outcomes (2)

• Incidence of adverse events in subjects treated with EPA +DHA

  16 weeks per subject

• Compilation of life habits & demographic information

  12 weeks per subject

Study Arms (3)

Monoglyceride (MAG)

EXPERIMENTAL

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

Triglyceride (TG)

ACTIVE COMPARATOR

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

Ethyl Ester(EE)

ACTIVE COMPARATOR

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

Interventions

MAG-EPA/MAG-DHA DIETARY_SUPPLEMENT

monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Monoglyceride (MAG)

TG-EPA/TG-DHA DIETARY_SUPPLEMENT

Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Triglyceride (TG)

EE-EPA/EE-DHA DIETARY_SUPPLEMENT

Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200

Ethyl Ester(EE)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCF Pharma: lead

Study Sites (1)

SCF pharma

Rimouski, Quebec, G0K 1P0, Canada

Location

Study Officials

• Samuel Fortin, PhD

  SCF Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded. Only the sponsor will have access to the randomisation list. No one at the sites will have access to the list.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, 3-arms parallel randomized study.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: December 18, 2019
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)