Keratec builds the science behind Cynatine
proposition of its sheeps' wool-derived keratin, Cynatine FLX, with
the release of data from its program of pre-clinical trials to back
up the ingredient's four-fold action for joint health.
Launched as a joint health ingredient in March, Cynatine FLX is a form of soluble keratin derived from the intermediate filament part of wool fiber.
Keratin is normally non-soluble but the company has developed a method of extracting it from wool in a soluble, digestible form by separating wool fiber into its constituent keratin parts without destroying its natural amino acid structure. This means that different parts of the fiber can be used for different kinds of products and applications.
Unlike glucosamine, which helps rebuild cartilage between joints, Cynatine FLX boasts a four-fold action:
As well as preventing joint breakdown and building resilience, it also has an anti-inflammatory effect, increases the antioxidant glutathione which activates the defense enzyme glutathione peroxidase, and provides direct antioxidant protection for cells.
"We feel we have much stronger science behind the four-fold action of the joint health product," Fertram Sigurjonsson, VP business development, told NutraIngredients-USA.com at last week's SupplySide West in Las Vegas.
"The pre-clinical studies strengthen our value proposition to the market."
The 10 trials were a mix of in vivo and in vitro studies. An in vivo rat study found the ingredient to have no effect on biochemical markers of toxicity; a mice study that found there was no effect on reproduction; a study in sheep showing that it is biocompatible; and a skin test on 51 human subjects and an in vitro study both showed up no skin irritation action.
In vitro, a human cell study showed that Keratec's keratin promotes cell health by stimulating proliferation, and another using primary sheep fibroblast cells also showed it promotes cell health; an AMES assay using rat liver indicated that it is not mutagenic; a study using bovine cells found it to be compatible with endothelial cells, which have an important role in wound healing; a hen's egg test indicated that it has no inflammatory activity; and a sheep cell study indicated that it does not alter T-cell response.
The release of this data does not mark the end of the science. Sigurjonsson said that the company is currently preparing some clinical trials which, like the pre-clincals, will be conducted at independent research organizations.
Since Cynatine FLX launched in March, Sigurjonsson said that many of the company's customers are using it to differentiate their glucosamine offering.
"Everyone has glucosamine. It is almost a commodity," he said. Sigurjonsson noted that other joint health supplement makers are choosing to differentiate using chondroitin or MSM (methylsulfonylmethane). MSM is the isoxidised form of dimethyl-sulfoxide, whereas chondroitin is commonly sourced from shark cartilage or cow trachea.
"The beauty is that it comes from sheep, in a sustainable manner. Our sheep are happy sheep," said Sigurjonsson.
So far, there is not yet a consumer product in the market containing Cynatine FX, but Keratec is currently working with a handful of companies that are developing products from capsules to nutrition bars and drinks. The first products are expected to be on shelves within three to six months.
In New Zealand, it is used both alone and in combination with glucosamine in capsules and drinks made by Wise Old Owl. In Europe, GSI has launched some nutrition bars containing the ingredient, and it has also been used in products by Sweden's SanPharm.
Prior to the launch of Cynatine FX earlier this year, Keratec was already producing keratin for the topical cosmetics market, which is distributed by Croda.
It plans to extend the Cynatine line with two new oral ingredients for the cosmeceuticals - one for skin and one for hair. It is anticipated that these will launch at Expo West 2006.
Keratec is building relationships with distributors, but for the moment it plans to distribute the Cynatine line itself.