Pharmacokinetics of Omega-3 Monoglycerides

What Was Tested

This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.

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.

It had two arms (groups): Monoacylglycerol (experimental) and Ethyl ester (active comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

The growing presence on the North American as well as European market of food products enriched with fish oil as a source of polyunsaturated fatty acids (PUFA) omega-3 in the diet requires evaluation and comment.

Research exploring health influence of the consumption of fish oil started in 1990 years.

Fish oil is the main dietary source of long-chain omega-3 PUFA.

For this purpose, reaching the recommended daily intake may require taking several capsules of fish oil per day.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Vitamin D, K2, Magnesium and Zinc and the comparison in turn, acting as their own control.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-11-11 with completion listed for 2011-03-31.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The absorption of EPA and DHA in the plasma (time frame: 0-5 hours). The bioavailability of EPA and DHA in the plasma (time frame: 0-24 hours).

It also tracked 1 secondary outcome, for example The maximum concentration of EPA and DHA in the plasma.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.