NCT03897660

MaxSimil and Vitamin K2: Determining Their Bioavailability

Completed NA Last updated 27 August 2020

What this trial tests

NA trial testing Omega-3 + vitamin K2 (TG form of omega-3) in Healthy in 22 participants. Completed in 31 March 2020.

Timeline

29 March 2019

Primary endpoint
23 November 2019

31 March 2020

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	22
Start date	29 March 2019
Primary completion	23 November 2019
Estimated completion	31 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Omega-3 + vitamin K2 (TG form of omega-3)
• Omega-3 + vitamin K2 (EE form of omega-3)
• Omega-3 + vitamin K2 [MaxSimil (MAG form of omega-3)]

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The benefits of a diet enriched with omega-3 fatty acids are multiple and confirmed by several clinical studies. Supplementation with vitamin K, a fat-soluble vitamin, can increase or maintain bone density in postmenopausal women and reduce the risk of fracture. In addition, some studies show that vitamin K may promote the absorption of omega-3 fatty acids. Fish oil, rich in omega-3, is one of the world's favorite forms of omega-3 supplements. However, many people suffer from gastrointestinal discomfort when ingesting fish oil capsules. To minimize these discomforts and improve plasmatic omega-3 bioavailability, Neptune Wellness Solutions has developed a patented formulation of fish oil called MaxSimil®, where omega-3s are in the monoglyceride (MAG) form, a predigested omega-3 form. This formulation has been tested in humans in a double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design. PK is defined as a monitoring of omega-3 levels in the blood by frequent blood sampling over a period of 24 hours following the ingestion of a single dose of omega-3. The results obtained showed that MaxSimil® omega-3s are 3 times more absorbed in the blood than the comparison formulation, a source of omega-3 in the ethyl ester (EE) form.

Although this first study confirms a greater bioavailability of MaxSimil®, a complementary PK study is necessary to confirm these results and to correct an important methodological bias. In fact, the pilot study did not include a comparator group where omega-3s were in the triglyceride (TG) form, the most widely omega-3 form currently consumed, but rather use an EE form, which have lower bioavailability than TG form. This may therefore have biased the study from the point of view of the comparator and thus give the impression that the comparator had been deliberately chosen to be less bioavailable than the MaxSimil®.

In order to confirm the superiority of MaxSimil® (omega-3 MAG form), both in terms of bioavailability and incidence of side effects, the aim of this study is to redo a PK study using this time two comparators, the two main forms of omega-3 currently used (TG and EE forms), as well as a supplementation with vitamin K2 (a form of vitamin K). Our hypothesis is that MaxSimil® will be associated with a better omega-3 bioavailability and a lower incidence of side effects than the other two forms (TG and EE), and possibly also with a better vitamin K bioavailability.

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. Pharmacokinetics of Supplemental Omega-3 Fatty Acids Esterified in Monoglycerides, Ethyl Esters, or Triglycerides in Adults in a Randomized Crossover Trial.
   Chevalier L, Vachon A, Plourde M. · · 2021 · cited 40× · PMID 33564872 · DOI 10.1093/jn/nxaa458