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NCT04382027

Pharmacokinetics of Omega-3 Monoglycerides

Completed NA Last updated 11 May 2020
What this trial tests

NA trial testing Omega-3 + vitamin K2 (monoacylglycerol form) in Healthy in 20 participants. Completed in 5 May 2020.

Timeline
11 November 2010
Primary endpoint
31 March 2011
5 May 2020

Quick facts

Lead sponsorUniversité de Sherbrooke
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment20
Start date11 November 2010
Primary completion31 March 2011
Estimated completion5 May 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Université de Sherbrooke — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

North American diets have insufficient omega-3 fatty acid (n-3 FA) content. Consequently, they display low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. A quick and easy way to increase the level of dietary n-3 FA is to take supplements. However, people report side effects in using the currently available supplements, such as gastrointestinal discomfort, nausea and gastric reflux; especially those where EPA and DHA are esterified as ethyl esters (EE). Moreover, EE supplements are less absorbed compared to other esterification forms, such as mono-, di- or triglycerides. The objective of this study was to test the pharmacokinetics of a new n-3 FA supplementation formulation rich in FAs esterified as monoacylglyceride (MAG).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Molecular Pathways and Roles for Vitamin K2-7 as a Health-Beneficial Nutraceutical: Challenges and Opportunities.
    Jadhav N, Ajgaonkar S, Saha P, Gurav P, et al · · 2022 · cited 52× · PMID 35774605 · DOI 10.3389/fphar.2022.896920
  2. Comparison of pharmacokinetics of omega-3 fatty acid supplements in monoacylglycerol or ethyl ester in humans: a randomized controlled trial.
    Chevalier L, Plourde M. · · 2021 · cited 22× · PMID 33011737 · DOI 10.1038/s41430-020-00767-4

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Université de Sherbrooke trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing