Nattokinase to become medical food for hyper-tension sufferers
increasing in popularity in the US as a supplement used by
sufferers of high blood pressure and other cardiovascular
conditions, should soon be available as a medical food with new
clinical research behind it. Philippa Nuttall reports.
Nattokinase was launched onto the US market by Amano Enzyme three years ago through the distribution channels of ET Horn. Since then sales of the supplement in capsule form have shot up, but the company now thinks the time is right to branch out and offer it in a variety of applications.
Kiran Krishnan from Amano Enzyme USA said that the company is currently looking at different ways in which nattokinase could be incorporated into a food.
"This could be confectionary, such as soft chews, or a drink or a snack bar," he told NutraIngredientsUSA.com. "We have also been working with Nutri Granulations to put the supplement into a drink," he said, adding that the company would like to launch a product in mid-2005.
Krishnan explained that the product's packaging would target it at people suffering from hyper-tension.
Clinical trials carried out in 2003, which are now waiting for publication, seemed to show the efficacy of nattokinase in treating and preventing heart disease and stroke.
Amano Enzyme is now looking to the end of the year when it hopes to begin new trials in Chicago. One trial, Krishnan explained, will take 20 patients and look at the relationship between the new markers set for cardio-vascular disease and nattokinase.
A second study will aim to further the understanding of the link between nattokinase's affect on blood viscosity - building on the results of last year's research. And, thirdly, the company is working to design a specific in vivo clinical assay to measure a patient's thrombolic activity when taking the supplement.
The group is also in talks with universities about setting up an animal model to prove clinically that the product works and how its efficiency compares to competing products.
Krishnan voiced his concern that other natto products on the market are not up to standard and could ruin the reputation of the supplement, particularly in the post-ephedra climate where the FDA is acting much quicker to remove products if there is any doubt about their safety and efficacy.
He fears that some distributors are simply looking at price rather than asking the right questions about the products.
NSK-SD nattokinase is a pro-fibrinolytic enzyme that helps to promote healthy circulation of the blood by breaking up cross linked fibrin and soluble fibrin monomers that may contribute to high blood pressure and other cardiovascular conditions.
Amano Enzyme claims that NSK-SD has the highest activity, greater than 20,000 fibrin units per gram, the highest levels of safety testing and the largest human clinical trials to date for nattokinase.
Krishnan said that in experiments carried out over the last six months, partly by a Japanese university and partly in-house, no other products - except NSK-SD - fitted the profile of nattokinase described by Dr Hiroyuki Sumi the scientist who discovered the enzyme.
To prove this, Krishnan said his company had developed an ELISA (Enzyme-Linked Immunosorbent Assay) designed to identify the characteristics of each enzyme structure.
"We found that our enzyme was identical to the structure agreed by Dr Sumi," he said.
He added that for the purposes of these tests, the researchers looked at the other four companies - as far as he knows - who make nattokinase. Two from Japan, one from Korea and one from Taiwan.
Unlike Amano Enzyme, which has been around since 1890, most of the other companies have been set up in recent years. Amano Enzyme is currently entering Europe, after three years of successful trade in the States.
"We began marketing nattokinase in the US in early 2002 and it is now our third most popular product out of a range of 50 products, including 13 dietary supplements, in terms of sales," said Krishnan, adding that the two best-selling products have been on the market for around 10 years.
Doctors have started to regularly suggest NSK-SD as an adjunctive therapy to blood pressure medication.
"Pre-reimbursement it is cheaper for the medical profession, working out at about 20 percent of the cost of a prescription drug," said Krishnan. Notwithstanding the cost, he noted that many patients prefer to take a supplement because it has less side effects.
