Produced by Kappa BioSciences, the K2Vital branded ingredient is a synthetic form of Vitamin K2 menaquinone-7 (MK-7).
The ingredient, which is derived from two flower extracts (geraniol and farnesol), is being positioned as an alternative to the natural soy-based MK-7 products currently on the market.
Kappa will start by supplying it to the dietary supplement market in the United States while it also prepares a GRAS (generally recognized as safe) dossier for its use in foods and beverages in the country. The firm will be working with a distributor in the US, and expects to announce the name of its partner within the next few weeks.
Kappa also plans to target the European market for both foods and supplements, but must first await approval from European regulators.
“We’ve submitted our data to a European member state for evaluation, but we have no idea when we’ll hear from them,” said CEO Dr Egil Greve.
Bioavailability, efficacy, safety
Kappa was established in its current form at the end of 2006, and since then the company has been focusing exclusively on research to back its ingredient, said Greve. It has completed four studies on K2Vital, which test its efficacy and bioavailability both in animals and humans, as well as a 90-day toxicity trial in rats. The studies have not yet been published.
The ingredient is developed via a proprietary technology, which allows for the manufacture of an product of up to 98 per cent purity, which is then diluted down to the concentrations required by customers (usually between 0.1 and 0.2 per cent grades).
The purification technology is also what allows for a lower price, said Greve. “Once we get up in volumes we have a much cheaper production process than that for soy-based ingredients,” he told NutraIngredients.com. He said the ingredient could come at $100 less per kg of 0.1 per cent formulation, based on current market prices. This is equivalent to a 20 per cent reduction in costs, he claimed.
Synthetic vs natural
Manufacturers of soy-derived MK-7 contacted by this publication suggested that the market is not yet ready for synthetic forms of the vitamin, even at lower prices. They would not discuss their own prices.
However, Kappa said it was not concerned about the synthetic characterisation of its ingredient.
“Kappa feels the market is ready and willing to accept a high quality, verifiable MK7 product regardless of the form or necessary production steps. The facts are that the starting material is extracted from two flower species. Following that extraction there are some reactions that would suggest the process may be better characterized as ‘synthetic’ versus natural, however the result is high purity MK7 product that can be assayed for and totally accounted for both qualitatively and quantitatively.”
K2Vital has been “extensively tested” for molecular identity using the standard HPLC method, said the firm. The HPLC chromatograms, it said, showed similar peaks for K2Vital as for natural natto derived MK-7.
K – benefits and 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.
Vitamin K has been shown to boost bone health and reduce the risk of osteoporosis. A significant body of evidence also exists supporting a role for the vitamin in enhancing cardiovascular health. Emerging evidence also supports a potential role for reducing the risk of prostate cancer, and boosting joint health.