Cholesterol Control: The Good, The Bad and The Innovative.
According to the American Heart Association's (AHA) latest statistics, every 26 seconds an American will suffer a coronary event, and about every minute someone will die of coronary heart disease (CHD) complications. The leading modifiable risk factor for CHD, as identified by AHA, is elevated serum cholesterol. Clinical studies have shown that lowering elevated total cholesterol, and specifically low-density lipoprotein cholesterol (LDL-C), through dietary and drug intervention therapies significantly lowers the risk of CHD. Yet the market is frighteningly large - as the AHA reports, 48 percent of all American adults have elevated blood cholesterol levels (200mg/dL and over).
While lowering one's LDL-C with statins was once the primary treatment option, dietary supplement manufacturers are putting their efforts behind natural ingredients for improving the favorable ratio of LDL-C and high-density lipoprotein cholesterol (HDL-C) cholesterol, resulting in better total cholesterol, as well as the addressing chronic conditions closely tied to heart health. They're also innovating delivery methods that provide finished product manufacturers with options consumers are responding to with sales.
"There seems to be a trend to avoid taking prescription drugs (statins) or to reduce the level of dependency on them. I believe this may be driven by the fear of side effects associated with statins," said Charles DePrince, president of Fuji Health Science, Inc. (Burlington, NJ). While statins are prescribed to lower LDL, it does not work to improve the favorable ratio between good and bad cholesterol, and has a different mechanism of how it works in the body, he explained. "One overwhelming trend that we are noticing is the consumer's willingness to try all natural products for their serious ailments," said Eric Weaver, PhD, CSO with Proliant, Inc. (Ankeny, IA). "Years ago, consumers solely relied on pharmaceutical drugs to cure their problems. More of these consumers have started to use natural products with their pharmaceuticals to enhance their quality of life."
In fact, according to Baldur Hjaltason, business development and sales manager with EPAS AS (Aalesund, Norway), many doctors are recommending that their high-cholesterol patients try omega-3 supplements before prescribing a drug, or at least take a supplemented omega-3 concentrate along with the drug. "Concentrated omega-3 supplements are now being used more not as a stand alone supplement, but with other ingredients or pharmaceuticals such as statins," he said. "There are several clinical studies going on that show the benefits of both lowering the total cholesterol and well as changing the ratio between the good and bad cholesterol. This might lead in the future to new pharmaceutical applications of combinations of omega-3 fatty acids and statins."
Addressing More Than Just the Bad
When looking at the cholesterol and heart health categories, Jeremy Moore, director of marketing and strategic development with Stratum Nutrition (St. Charles, MO), expressed that they are fairly mature, especially when triglyceride control is part of the equation, which is dominated by omega-3 fish oils, and noting that phytosterols and red yeast rice have a strong presence. To that end, he sees growth opportunity in products that address the management of specific risk factors important for maintaining good cardiovascular health.
"Many scientists now believe that controlling the oxidation of LDL-C, not just the level of LDL-C, is very important for arterial health," said Moore. "This is because the oxidation of LDL-C within the artery wall leads to a series of events resulting in the formation of fatty streaks in the artery tissue. Given time and the right conditions, these fatty streaks can eventually morph into arterial plaque."
ATRINIA (Chitin-glucan), a novel vegetarian fiber ingredient that supports clean, healthy arteries as a unique approach to cardiovascular health, is Stratum's newest innovation. A unique composition with optimum ratio of chitin and 1,3 beta-glucans, which combines the benefits of both soluble and insoluble fibers for maximal performance, ATRINIA does not directly address cholesterol control, but the company's science supports the decrease in oxidation of LDL - ultimately supporting clean, healthy arteries.
A 28-day, single-blind, placebo-controlled pilot study conducted at the Hospital Center of the University of Liège, Belgium (Diabetology, Nutrition and Metabolic Diseases Department)1 concluded that chitin-glucan was safe, well tolerated and decreased oxidized LDL-C by approximately 26 percent. Stratum has additional studies underway to confirm previous pilot study results and evaluate additional biomarkers of lipid and carbohydrate metabolismand oxidative balance.
"Total cholesterol and LDL-C are recognized risk factors that consumers know about and are interested in, so we see a good opportunity for growth in products and ingredients that support healthy blood lipids," said Moore. "This is an area that many see as important because the oxidation of LDL-C is thought to be the first step in a cascade of events that leads to atherosclerosis and, consequently, heart disease. What this means in consumer terms is that ARTINIA supports clean, healthy arteries. Our market research supports that this is a really appealing mechanism to consumers."
While Proliant also views lowering LDL-C as a primary concern in controlling one's cholesterol, Weaver expressed a recent revelation between inflammation and cholesterol, and how his company is addressing it.
"The most exciting recent data I have seen recently on cholesterol is the effects of low-grade inflammation on cholesterol status," he said. "Our market should not need a reminder that the body, including cholesterol metabolism, is not compartmentalized. BMI, diet, inflammatory status and age are all major contributors to the body's regulation of LDL-C and HDL-C. Endotoxin, a bacterial by-product in the lumen, is a molecule in the gut that can cause chronic inflammation and reduce HDL if it is absorbed.2,3 So we see more interest in products to address chronic conditions, particularly those associated with aging."
ImmunoLin has been the main product Proliant has marketed and sold for the past 10+ years, and it has performed two clinical studies to show the effects it has on cholesterol. Weaver feels confident the strides Proliant has made with the ingredient also mark the future of the category.
"At the time of the publication that ImmunoLin lowers cholesterol in 2005, there was interest in the lower cost products such as soy and phytosterol products. Since then, the subdued excitement in both of these products by the cardiovascular market has been replaced with interest in ingredients, which can also impact inflammation," said Lauridsen. "We believe the future ingredient cholesterol control market will be fueled by the formulas to affect both cholesterol and inflammation rather than single entity products for lowering cholesterol."
Elevating the Good
The newest factor of cholesterol management emerging in consumer awareness is the increase in HDL-C, offered Fuji Health Science's DePrince.
"For years the consumer was convinced that cholesterol must be reduced, but they are slowly beginning to also recognize the importance of a balance between good and bad cholesterol," he said.
Fuji has been producing astaxanthin for the dietary supplement industry for 15 years, and during this time the company has sponsored more than 40 studies in various health benefit areas. However, cholesterol control specifically is a relatively recent addition.
"Cholesterol control has been a more recent part of our program," explained DePrince. "Astaxanthin induced modification of cholesterol has been observed in animal studies, but with the publication of the Yoshida study in October 20095, these effects are now also demonstrated in a double-blind, placebo controlled human study. The administration of astaxanthin at doses of 12 and 18mg/day significantly reduce triglycerides and increased HDL-C as well as adiponectin in humans."
While fish oil concentrates containing omega-3 fatty acids EPA and DHA are largely accepted ingredients in the heart health area - the greatest number of scientific papers are associated with hearth health, which is reflected in the fact that more than half of consumers link fish oil derived omega-3 fatty acids with hearth health benefits, according to EPAX AS's Hjaltason - recent data shows that one third of the uses for condition specific omega-3 supplements were to address heart diseases followed closely by high cholesterol.
"The American consumer has been educated that there are three main indicators linked to increasing the risk of getting heart diseases: total blood fat, amount of cholesterol and blood pressure. Marine-based omega-3 fatty acids affect all of those risk factors," he said. "It has been well proven that omega-3 fatty acids lower the blood fat content and we now have a prescription drug for such uses based on highly concentrated EPA and DHA.
While Hjaltason pointed out the majority of omega-3 product sales in the US is for well-being products containing un-concentrated EPA and DHA, which offer long-term protection against cardiovascular diseases including high cholesterol, the biggest growth and the focus of EPAX's business has been in condition-specific products that are highly concentrated omega-3s. "These products are for those at a higher risk than normal populations," he said. According to the AHA, individuals who have survived a heart attack have an increased probability of illness and death that is 1.5 to 15 times greater than that of the general population. "A higher dosage is needed than what regular concentrates can offer."
The company's bestseller in the cardiovascular area is EPAX 6000TG - a product with which EPAX has conducted the most clinical trials (more than 40) for cardiovascular research alone. EPAX 6000TG contains 300mg/g of EPA and 200mg/g of DHA - the right ratio for cardiovascular protection including changing the ratio of good and bad cholesterol - and is offered in both the natural triglyceride form or as ethyl esters.
New Omegas, New Deliveries
Luis E. Echeverria, new business development manager with Evi, Inc. (Miami, FL), sees the omega-3 category continuing to dominate the cholesterol control category, pointing out that the omega-3 category was a $100 million category in the 2002 and is expected to reach $7 billion by 2011. "This exponential growth reflects the interest of consumers in improving their cardiovascular health and with all the publicity and good press that omega-3s have received toward fighting cardiovascular issues this trend will not stop," he said.
However, as consumers continue educating themselves about what they should nurture themselves with, Echeverria predicts they also demand. higher quality and more effective products. Where fish oil and algae-sourced ingredients are viewed as the top two ingredient sources of omega-3s, his company is focused on the ALA subcategory. While ALA is most known for flaxseed, Evi is addressing a sub-category source rapidly gaining momentum: chia.
"There are two things about chia that sets it apart from its side-to-side competitor flaxseed," said Echeverria. "First, the content of omega-3 in its oil is much higher, which is good because the higher the concentration of ALA in the ingredient, the higher the conversion to EPA and DHA. Second, chia naturally has antioxidants within the seed. This makes it extremely stable and won't go rancid as flaxseed does. (Some flaxseed in ingredients solve this problem by adding antioxidants to the formula but that is added cost that is not necessary with chia.)"
Because of these two main differences, Echeverria has observed formulators' interest and how they have started to develop products with chia seeds and chia-based ingredients. "This seems to be a growing trend and we expect to see more chia-based ingredients in more products in the near future," he said, adding that Evi began supplying OrganexChia™ as milled chia, chia oil and chia flour this year and will obtain its EU Organic Certification so it can begin supplying the European market as well. "All of those items have particular applications depending on what type of product wants to be developed."
Another hybrid of the omega-3 category is Enzymotec USA (Morristown, NJ) omega-sterols, which work to inhibit the absorption of cholesterol through digestion. And like Evi, Enzymotec is focused on giving product manufacturers flexibility.
"Our approach is to offer not new science, but novel and proprietary delivery systems, which enable greater efficacy, potency or bioavailability to alreadyestablished nutrients," said Elzaphan Hotam, CEO. "Such is our proprietary omega-sterols conjugate, which offers a synergistic effect of both omage- 3/DHA-EPA and sterols-esters and the fish phospholipids complex we carry exclusively. Combinations of those or similar nutrients so that a more comprehensive effect could be achieved are also an area which we believe could dominate. That would be on top of creating a point of differentiation for those who seek this position.