Alltracel reports new findings on mechanism
novel cholesterol-lowering technology backing initial findings of
efficacy in animal research.
The company has developed a range of products based on polysaccharides derived from cotton, including a wound care product applied topically to stop bleeding rapidly.
Last spring it announced that a three-month study on mice had demonstrated its m-doc technology to cause significant reduction in total cholesterol and an improved HDL/LDL ratio.
The research indicated significant potential for use in cholesterol-lowering foods and led to a development agreement with Scottish sausage casings maker Devro.
However proof of the mechanism and safety and efficacy trials in humans, as well as tests on delivery methods are all required before new foods reach the market.
Ciaran O'Reilly, technical director at Alltracel, said: "Last year's breakthrough results on animals gave us a hypothesis for the mechanism, which was some kind of interaction in the bloodstream. But our new findings have raised an alternative mechanism."
The research team at UCD's Conway Institute of Biomolecular and Biomedical Research found m-doc interactions with cholesterol, bile salts and very low density lipoproteins in the gut.
"One of the functions of bile salts is to extract proteins from what you eat. If the bile salts are bound with the m-doc particles than they are not very efficient in extracting cholesterol," suggests O'Reilly.
Plant sterol-containing foods also work by preventing absorption of cholesterol in the gut. It is thought that they either reduce the solubility of cholesterol or, because they are very similar in structure with cholesterol, they compete with cholesterol for space in the micelles, structures that solubilise lipids in the intestine. This in turn results in less cholesterol being transported into the blood stream.
The insight into the mechanism of interaction of m-doc with cholesterol will optimise current and future clinical trials and influence the commercialisation route.
"There may be a number of mechanisms involved, one does not rule out the other," noted O'Reilly. "They will help guide us on how we market the product, influencing issues with the timing of delivery. For instance it makes a difference if it works in the intestine or on the bloodstream."
Cholesterol remains the single biggest modifiable risk factor for coronary heart disease, which kills more than 120,000 people every year in the UK alone. In the UK half of the population is said to have high cholesterol levels, making this a key market for functional food manufacturers.
A Frost & Sullivan report on plant sterols forecasts growth between now and 2010 at 15 per cent annually over this period.
Alltracel is expecting to release results from its human clinical trials this spring.
