MaxSimil and Vitamin K2: Determining Their Bioavailability

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

In addition, some studies show that vitamin K may promote the absorption of omega-3 fatty acids.

It had three arms (groups): TG form of omega-3 (active comparator), EE form of omega-3 (active comparator) and MaxSimil (MAG form of omega-3) (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

Long Chain-Polyunsaturated fatty acids (LC-PUFA) are needed to support normal physiological functions: Unlike saturated and monounsaturated fatty acids, synthesis of eicosapentaenoic acid (EPA, 20:5 omega-3) and docosahexaenoic acid (DHA, 22:6 omega-3) from its omega-3 PUFA precursor, alpha-linolenic acid (18:3 omega-3), is extremely limited in humans.

Thus, it is recommended that DHA be obtained from dietary sources such as fish and seafood.

Intake of EPA and DHA from fish normally correlates positively with the concentrations of EPA and DHA in plasma.

At sufficient levels of cellular content, the LC-PUFA influence the physical nature of cell membranes and membrane protein-mediated responses, lipid-mediator generation, cell signalling, and gene expression in many different cell types.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female aged 18-65 years (inclusive). Body mass index between 18.5 and 29.9 kg / m² (inclusive) at the pre-selection visit. Women of childbearing potential should use an approved method of contraception for the duration of the study so that they do not become pregnant during the study.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: menopause or pre-menopause with amenorrhea\> 6 months; malnutrition (assessed by albumin, hemoglobin and blood lipid levels); history of current or past alcohol and / or drug abuse.

How the Study Was Run

The set-up was 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.

Each person switched between Vitamin D, K2, Magnesium and Zinc and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

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

It started in 2019-03-29 with completion listed for 2019-11-23.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Determine the bioavailability of omega-3 and vitamin K2 according to the forms ethyl ester (EE), triglycerides (TG) and MaxSimil® (monoglycerides, MAG): Calculating the area under the curve (AUC) 0-24h as the first parameter of the PK. Determine the bioavailability of omega-3 and vitamin K2 according to the forms ethyl ester (EE), triglycerides (TG) and MaxSimil® (monoglycerides, MAG): Calculating the AUC 0-6h (absorption study) as the second parameter of the PK. Determine the bioavailability of omega-3 and vitamin K2 according to the forms ethyl ester (EE), triglycerides (TG) and MaxSimil® (monoglycerides, MAG): Calculating the maximum concentration as the third parameter of the PK.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 22 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.