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Pharmacokinetics of Omega-3 Monoglycerides

NCT04382027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-05-11

No results posted yet for this study

Summary

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).

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Omega-3 + vitamin K2 (monoacylglycerol form)

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form. Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments.

DIETARY_SUPPLEMENT

Omega-3 + vitamin K2 (ethyl ester)

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form. Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments.

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Melanie Plourde, PhD · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-11
Primary Completion
2011-03-31
Completion
2020-05-05

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 NCT04382027 on ClinicalTrials.gov