Heart health claim expected end of 2011 for vitamin K2, says NattoPharma

Speaking to DairyReporter.com, the recently appointed CEO of the Norwegian raw material supplier, Peter Carlsson, said that the company has been working extensively on developing the science to support regulation in this area.

The European market for Vitamin K2 opened up last year when the EU authorities granted the ingredient Novel Foods approval. A positive European Food Safety Authority (EFSA) opinion on bone health claims provided a further boost, although a negative opinion was delivered on heart health.

Carlsson added that it is “our judgement that we will have provided EFSA with sufficient efficient to demonstrate causality ​between the dietary intake of vitamin K2 and the normal function of the heart and blood vessels,”​ for the authority to back such a claim next year.

EFSA endorsed a health claim in October 2009 for the dietary intake of vitamin K and the maintenance of normal bone and normal blood coagulation but the Parma based agency concluded that there was inconsistency in studies submitted to demonstrate vitamin K2 and its benefits for cardiovascular health.

Growing awareness of vitamin K​

“We have very much moved on from exploratory science approach to one of application science, and we really see 2011 as the breakthrough year for our vitamin K2 brand – MenaQ7. ​

The company is beginning to really see the fruits of its market education drive with considerable awareness now by both industry and the consumer of the benefits of vitamin K2 and our MK-7 product, which is sourced from the fermented soy product natto​,” continued Carlsson.

The CEO also cited the considerable interest shown in regard to MenaQ7 at the trade event, HIE, in Madrid last month, with positive feedback both from the SME and larger scale food manufacturers in the active ingredient.

Industry collaboration ​

The previous exclusive agreement NattoPharma had with Danisco, its distributor in the market segment for fortified food, was amended in September this year to be a non-exclusive agreement.

Carlsson said the move in no way reflects a change in its working relationship it has with Danisco but allows the Norwegian supplier to have “multiple partners in the food market” ​and that the change was “in line with what the company has previously made within the dietary supplement market.”​

He said that following that amendment NattoPharma “has established a dialogue”​ with several of the leading players in the market to accelerate speed to market of foods enriched with vitamin K2, and it expects the first food products to hit the shelves in 2011, with the dairy sector leading the pack on products with a bone health positioning.

Main forms​

There are two main forms of vitamin K: phylloquinone, also known as phytonadione, (vitamin K1) which is found in green leafy vegetables such as lettuce, broccoli and spinach, and makes up about 90 per cent of the vitamin K in a typical Western diet; and menaquinones (vitamins K2), which make up about 10 per cent of Western vitamin K consumption and can be synthesised in the gut by microflora.

Menaquinones (MK-n: with the n determined by the number of prenyl side chains) can also be found in the diet; MK-4 can be found in animal meat, MK-7, MK-8, and MK-9 are found in fermented food products like cheese, and natto is a rich source of MK-7.

Bioavailability ​

The MK-7 form is said to be the most bioavailable and bioactive form of Vitamin K2, and according to Professor Cees Vermeer from the VitaK research centre in Maastricht, it is the best choice for food fortification.

“Bacillus natto produces vitamin K2 (in the form of MK-7) so efficiently that it is possible to prepare extracts that can be used for food enrichment. The ferments used in dairy produce slightly different forms of K2 (MK-8 and MK-9) but at substantially lower concentrations.”​
And he maintains that the main advantages of the MK-7 form is that the concentration in the end product can be accurately controlled.

Professor Vermeer, a global leader in vitamin K research, told this publication that the synergistic effect of vitamin K2 in combination with calcium and vitamin D is a critical factor to bear in mind when fortifying foods.

“These three ingredients should be used in products together to optimise bone health, and, for that reason, dairy applications are the ideal delivery system,” ​he explained.

Poor vitamin K2 status, said the researcher, is a strong and independent risk factor for cardiovascular disease and mortality.

“Unfortunately, there are very few food products rich in vitamin K2,” ​continued the Professor, adding that most apparently healthy adults are insufficient with respect to vitamin K2.

This deficiency, he explained, results in incomplete activation of the vascular calcification inhibitor MGP and thus in sub-optimal protection against hardening of the arteries.

Professor Vermeer said that the VitaK laboratories have been conducting clinical trials into NattoPharma’s MK-7 brand, MenaQ7, and its effect on function of the heart and blood vessels, with the first data expected by the end of 2011.