By Elaine Watson, Nutra Ingredients USA
The first products containing a novel fiber claimed to reduce oxidized LDL cholesterol - an emerging risk factor for atherosclerosis - could hit shelves in the US next year, creating a new category in the cardiovascular health market.
Artinia - a chitin-glucan fiber from the fungus Aspergillus niger marketed by Stratum Nutrition – was unusual in that it helped firms boost fiber in everything from muffins to smoothies, but also opened up a novel approach to heart health by controlling the oxidation of LDL cholesterol in the arteries, Stratum global business director Jeremy Moore told NutraIngredients-USA.
The oxidation of LDL led to a series of events that resulted in fatty streaks in artery tissue, which in turn morphed into arterial plaques, said Moore, making OxLDL levels arguably a more useful predictor of risk for developing cardiovascular disease than total cholesterol or LDL-cholesterol, he claimed.
Stratum Nutrition, which plans to engage with consumers about Artinia by focusing on ‘supporting healthy arteries’, is in talks with several US food and drink and supplement manufacturers about new product launches, revealed Moore.
“We’re talking to some major branded food companies, while the first supplement with Artinia should launch early next year. In the meantime, we’ll continue to try to establish the relevance of the biomarker.”
Biomarkers and cardiovascular disease
While cholesterol or blood pressure were the best known biomarkers, others from the inflammatory biomarker C-Reactive protein to homocysteine were now starting to attract more attention, claimed Moore.
Meanwhile, controlling LDL oxidation and inhibiting platelet aggregation were also now regarded by the European Food Safety Authority (EFSA) to be beneficial to cardiovascular health, said Moore, citing recent positive opinions from EFSA on the ability of olive oil polyphenols to protect LDL from oxidative damage, and the tomato extract Fruitflow to inhibit platelet aggregation.
Human clinical studies
Results of a double-blinded, placebo-controlled, multi-site clinical trial into the cardiovascular benefits of Artinia for people with elevated cholesterol were currently being prepared for submission for peer review, which should hopefully be accepted for publication in the next 60-90-days, revealed Moore.
The results of the new – much larger - study confirmed what a 28-day pilot study conducted on a small number of healthy males had already demonstrated, that Artinia reduced oxidized LDL cholesterol, he said.
“Obviously getting this peer reviewed and published is a key step for us, but what we are trying to establish is whether we will need to conduct a second clinical study so we have the ‘two well-controlled clinical trials’ the FTC (Federal Trade Commission) and the FDA (Food and Drug Administration) seem to be looking for.
“We are prepared to invest in this, provided we have a high degree of confidence that this will help us get to the next step with Artinia. We are confident about the science, and we are having very candid discussions with potential customers about what is required.”
Talking to consumers about chitin-glucan
While consumers might struggle with the word chitin-glucan or the concept of oxidizing LDL cholesterol, they responded well to claims about promoting clean, healthy arteries, according to research conducted by the Natural Marketing Institute, suggesting this could be a new area of opportunity for food manufacturers in the cardio health market, said Moore.
“I think on the front of pack, talking about Artinia as a fiber that promotes healthy arteries is probably the best approach, even though on the ingredients declaration you have to call it chitin-glucan, which most consumers probably won’t recognize.”
Food and drink applications
A free-flowing, odorless light yellow/brown powder that “behaves like an insoluble fiber”, Artinia had been tested in a wide range of food and drink applications from drinkable yogurts and smoothies to bread, cookies, muffins, cereals and nutrition bars, said Moore.
“It works in almost anything apart from clear beverages. In bread, it increases shelf-life because it helps with moisture retention. Manufacturers like it because it doesn’t increase viscosity and it doesn’t have a cereal taste.”
Organoleptic and sensory evaluation of Artinia in smoothies revealed it added no off-tastes, cereal notes, or sliminess, while it also survived the pasteurization process, he said.
“Artinia is not the only ingredient that affects oxLDL levels, but it’s very unusual in that it’s also a fiber.
“If you’re talking about hydroxytyrosol [an antioxidant in olive oil shown to reduce oxLDL] it’s good in its pristine state, but what if it has been sitting around in a warehouse for weeks? You don’t have to worry about this with Artinia, it’s inert, it’s not really an antioxidant in and of itself.”
The size of the prize
Market data unveiled by Windrose Partners president Greg Stephens at the SupplySide East show in May suggested that new product launches in the US food, drink and dietary supplements market on a heart health platform had tripled in the past five years, and now account for 1.5% of all new product launches.
“More education is needed,” said Stephens, “but consumers are beginning to learn that cholesterol is only one biomarker of cardiovascular health; we are even starting to seeC-reactive protein talked about in the mainstream media.”
Sales of US heart health ingredients (wholesale) topped $563m in 2008 and were predicted to exceed $1bn by 2012, reflecting a compound annual growth rate of 20%, he added.