© 2023 MJH Life Sciences™ and Nutritional Outlook. All rights reserved.
The market for heart-health products, especially those for cholesterol management, can go nowhere but up.
What do nearly half of U.S. adults have in common? They all have high or elevated cholesterol, say the Centers for Disease Control and the American Heart Association.
While this isn’t good news, it does translate into opportunity for heart-health marketers. According to Nielsen Label Trends and Innova Market Insights, as recently as 2008, Americans spent $11 billion on foods with heart-health claims like “cholesterol-free” and “reduced cholesterol.” That same year, 3500 products with heart-health claims were launched globally, including 1300 in the United States. Of these new products, bakery and cereal took the largest share (24%), followed by dairy (16%).
Cargill Health & Nutrition (Wayzata, MN) is among those trying to take advantage of this win-win situation for suppliers of natural products: they can do well by doing good.
Cargill’s forays into this area include CoroWise plant sterols and Barliv barley betafiber. CoroWise is derived from plant sterol esters. The company says eating food products enriched with plant sterol esters helps promote healthy blood cholesterol levels. Barliv, a concentrated beta-glucan soluble fiber derived from whole grain barley, has been clinically shown to reduce cholesterol when consumed as part of a low-saturated-fat, low-cholesterol diet.
Enzymotec Ltd., an Israeli company with U.S. offices in Morristown, NJ, also includes sterols in its ingredient lineup. CEO Elzaphan Hotam says that Omega-Sterols offer benefits similar to the company’s CardiaBeat product, which is now confined in the United States to the medical foods/Rx channel.
Among their benefits, he claims, Omega-Sterols feature the most compact delivery form of both sterol esters and omega-3. Two, Omega-Sterols are already adapted to recent FDA changes, scheduled to take effect at the beginning of 2012, which will restrict heart-health claims to sterol ester products, disallowing such claims for products that are a mixture of both sterols and fish oil. Hotam describes Omega-Sterols as “a unique form of sterol esters, having eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids attached to their backbone.” And three, the ingredient boasts five patents and Generally Recognized as Safe (GRAS), New Dietary Ingredient (NDI), and Novel Food status.
In addition, says Hotam, a clinical study has shown that the following structure-function claims back Omega-Sterols: 1) 15% better triglyceride reduction compared to an equivalent amount of fish oil, and 2) does not hinder vitamin absorption (as sterol esters tend to do, he says). “Further, the triglyceride-reduction effect may be the result of better absorption of EPA/DHA when combined with the sterols.”
Other Enzymotec products for heart health are Krill Oil+ and Omega-Choline. The former is believed to facilitate better absorption of EPA/DHA, and the latter to enrich the diet with additional fish-derived, omega-3–based phospholipids to further support essential organs, including the circulatory system.
At Danish firm Danisco, the news is about a long-term agreement with U.S.-based Arboris LLC (Savannah, GA). Together, the companies will have a stronger presence in marketing pine tree–derived phytosterols produced by Arboris. In an April press release, Danisco explained that phytosterols are naturally occurring compounds with proven ability to reduce cholesterol. In addition, it stated, the compounds are backed by more than 200 human intervention studies and enjoy health-benefit recognition from regulatory authorities worldwide.
Why are sterols effective in maintaining heart health? Laura Troha, brand management and marketing communications manager for Cognis Nutrition & Health, supplier of Heart Choice natural plant sterols and sterol esters, explains, “The molecular structure of plant sterols is almost identical to cholesterol (animal sterols). Because our bodies can’t tell the difference, they accept plant sterols as though they were cholesterol, blocking the absorption of dietary cholesterol into the bloodstream.”
Troha, whose La Grange, IL–based company is now a part of BASF, notes that Cognis’s other heart-health products are Omevital omega-3 fatty acids and Covitol natural vitamin E.
Troha says, “Greenland Inuits have a low incidence of CVD, which correlates with their high intake of fish oils. Omega-3 fatty acids seem to actively protect the heart because over time, the development of atherosclerosis narrows blood vessels, and the heart cannot get enough blood. Omega-3 fatty acids not only influence the atherogenic process but also regulate serum lipids. Omega-3s have been shown to reduce the adhesion of blood platelets, contribute to lower blood pressure, and reduce inflammatory reaction.”
Over the past three decades, omega-3 has gone from virtually unknown to a household word. Not only is this ingredient found in dietary supplements, but in foods and body-care items as well. And it is no longer sourced from fish alone.
Eric Anderson, vice president of sales and marketing for Aker BioMarine Antarctic US (Metuchen, NJ), says that one capsule of his company’s Superba Krill oil contains 500 mg of pure Antarctic krill oil, providing 90 mg of EPA and DHA omega-3 fatty acids. He claims that krill is a “superior” source of omega-3 because it delivers the substance in phospholipid form, mainly as phosphatidylcholine. “Omega-3 availability is increased when delivered by phospholipids compared with other sources, due to more efficient absorption of omega-3 phospholipids in the small intestine.” A side benefit, he suggests, is that there is less burping than with omega-3 derived from other sources. Of note, FDA recently accepted a self-affirmed GRAS notification for Superba Krill, as well as a NDI notification.
EPAX AS, also from Norway, has received recent honors for its marine-derived EPA/DHA omega-3 fatty acids, including a 2011 award from Friend of the Sea and a fourth consecutive annual Top Supplier designation from pharmaceutical firm Banner Pharmacaps Inc.
EPAX claims to have “the most clinically documented omega-3 ingredients, available with more than 100 published studies. Integrated quality control and assurance throughout the entire supply chain ensures traceable, safe, and reliable products.”
Sergey Strusov, PhD, vice president of research and product development for Novotech Nutraceuticals Inc. (Ventura, CA), says his company is offering a new form of omega-3 product-powder.
Strusov says the powder contains the same amount of EPA and DHA as original fish oil formulas. In addition, he indicates, it enables easier handling and has longer shelf life and better taste. The powder form is very stable mechanically and may be incorporated into virtually any product, including tablets, capsules, pills, and food. It is especially suited for applications involving high-pressure processing, Strusov adds.
Not all omega-3 comes from the sea. Proprietary Nutritionals Inc., in Kearny, NJ, says its Benexia is an organic, gluten-free whole grain sourced from chia. President Dean Mosca says chia oil contains more than 21% alpha linolenic acid (ALA). He cites a global summit on Nutrition, Health & Human Behavior, held earlier this year in Belgium, which recommended a “reduction in LA (linoleic acid) and an increase in ALA (alpha linolenic acid) in human and animal diets” in order to reach necessary tissue-concentration targets. Heart-health benefits include support of healthy blood pressure and cholesterol levels, as well as support of a healthy inflammatory response, says Mosca.
Like sterols and omega-3 fatty acids, carotenoids are a big player in heart health. These nutrients are believed to exert significant antioxidant activity in the body.
Found mainly in foods of red, yellow, or orange hue, carotenoids manifest mainly as alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, zeaxanthin, and lycopene. Alpha-carotene, beta-carotene, and beta-cryptoxanthin are provitamin A carotenoids, meaning they can be converted by the body to retinol (vitamin A).
Sourced from Vietnamese gac fruit, Carogac, from Telos Ceuticals LLC (Walled Lake, MI), is said to be rich in alpha-tocopherol; omega-3, -6 and -9; and vitamin C. Moreover, it is over 40% fiber. According to the company, it has been shown to have 240 times more lycopene than tomatoes, 65 times more beta-carotene than carrots, 40 times more zeaxanthin than corn, and twice as much vitamin C as oranges.
Cofounder Tom Morse says the ingredient is available in stable freeze-dried powder and aseptically packed purees, making it suitable for supplements, beverages, baked goods, and cosmetic/personal care applications.
Describing the benefits of Carogac, Morse says, “High levels of plasma antioxidants, especially carotenoids like lycopene and beta-carotene, have been shown to decrease carotid thickness and therefore slow the progression of atherosclerosis. This will in turn decrease the rate of heart attack in the long run.”
Resveratrol is another antioxidant building a following. Antioxidants are known for scavenging free radicals associated with low-density lipoprotein (LDL) cholesterol. Many believe that nitric oxide, a critical component of heart/artery function, allows blood vessels to “relax,” which enhances blood flow. In a 2003 animal study published in the International Journal of Molecular Medicine, a high-cholesterol diet decreased nitric oxide by about a third.
Jeremy Bartos, PhD, ingredients product manager at Irvine, CA–based pTeroPure, says that his company’s ingredient is 99%-pure all-trans pterostilbene. According to Bartos, “Pterostilbene, like resveratrol, is a natural stilbenoid found in small berries such as blueberries and grapes. Both are phytoalexins, chemicals that are part of the plant’s defense system, and are produced when the plant is under attack by pathogens such as bacteria or fungi.”
He continues, “The main difference between pterostilbene and resveratrol is that pterostilbene contains two methoxy groups and one hydroxyl group, while resveratrol has three hydroxyl groups. The two methoxy groups cause pterostilbene to be more lipophilic (oil soluble) than resveratrol, which increases oral absorption and gives it a higher potential for cellular uptake. Pterostilbene also has a much longer half-life in the blood than resveratrol (105 minutes versus 14 minutes), which gives it more time for its antioxidant activities to act.”
Bartos cites published reports showing that pterostilbene functions as a PPAR-alpha activator that helps decrease triglyceride and very-low-density lipoprotein (VLDL) synthesis. He reports that a USDA study group demonstrated that pterostilbene activates PPAR-alpha in vitro better than all compounds tested, including both resveratrol and the pharmaceutical ciprofibrate. He adds, “Subsequent structural and in vivo studies confirmed the correlation between pterostilbene’s activation of PPAR-alpha and cholesterol lowering.”
Indena S.p.A. (Milan) also takes an antioxidant approach to maintaining cardiovascular health. Christian Artaria, marketing director and head of functional food development, says the company focuses on protection of LDL particles from oxidative damage. He notes, “The antioxidant/atherosclerosis hypothesis was based on the observation that oxidized low-density lipoproteins stimulate the formation of lipid-laden macrophages and foam cells, thus potentially contributing to the onset of atherosclerosis via the formation of plaques.”
Artaria cites a recent evaluation by the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition, and Allergies (EFSA-NDA) that states that a reduction of LDL oxidation would benefit people around the globe. Indena’s Leucoselect Phytosome, a grape seed extract that has been the focus of four clinical trials, has been shown to improve plasma oxidative status of healthy volunteers in different conditions, reduce LDL susceptibility to oxidative stress in heavy smokers, and improve oxidative stress levels in diabetic patients.
Sytrinol, from Proprietary Nutritionals, is yet another antioxidant nutrient aimed at cholesterol and triglyceride lowering. Noting that it works in as few as 30 days, Dean Mosca says it is a blend of polymethoxylated flavones (PMFs) and a range of palm (alpha, delta, and gamma) tocotrienols. Mosca remarks, “Studies have revealed that Sytrinol is able to significantly lower total cholesterol, LDL, and triglycerides. Better still, the formula has also been shown to increase high-density lipoprotein levels.”
Protein and fiber are two major components of oats. The outer casing, or bran, is believed to lower LDL cholesterol and possibly to reduce the risk of heart disease. The protein is judged nearly equivalent to soy protein.
CreaNutrition AG, a subsidiary of Swedish Oat Fiber (Zug, Switzerland), says that bioactive oat beta-glucan, a soluble fiber, is the cholesterol-lowering constituent of its oat bran ingredients. In December of 2010, EFSA published a positive opinion on the following disease risk-reduction claim: “Oat beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of heart disease.” Although the health claim still needs to be approved by the EU Commission, CreaNutrition proudly notes that “healthy eaters” have been enjoying oats for decades. It further points out that scientific reports linking oat consumption to cholesterol reduction have been around for approximately 50 years.
Jean Hegge, marketing director for Solae (St. Louis, MO), describes soy protein as “a high-quality, complete protein that is comparable to animal protein from beef, milk, or eggs.” Moreover, she says, “Soy has been clinically proven to lower cholesterol. For every 1% decrease in serum cholesterol, there is a 2 to 3% reduction in the rate of coronary heart disease.”
In 1999, FDA approved a soy protein health claim, and 11 other countries endorse similar claims today. In the United States, the claim reads: “25 g of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”
Solbar (St. Paul, MN) also markets soy proteins. Hadar Sutovsky, isoflavones global sales manager, says these products-designed as low-calorie/high-nutrient meal supplements-can contribute to weight reduction and thereby reduce the risk of cardiovascular disease.
The line includes five protein products ranging from 50% protein content up to 90%. There also is a natural soy isoflavone extract called Solgen, which can be used for dietary supplements, nutritional foods, beverages, and cosmeceuticals. Solgen is available in concentrations ranging from 3 to 40%.
CoQ10 has long been linked to heart health. In April, Jarrow Formulas announced the launch of two new QH-absorb products: a 100-mg 120 softgel size, and a 200-mg 60 softgel size. The company states that QH-absorb, which features the active form of CoQ10 known as ubiquinol, offers improved bioavailability over the more commonly seen ubiquinone CoQ10 supplements. A press release asserts, “[Ubiquinol] is able to deliver CoQ10 in its native antioxidant-ready (reduced) form. While standard CoQ10 (ubiquinone) supplements can be activated in the body, this activation may be less efficient in some individuals due to age, state of health, or genetics.”
Meanwhile, Jarrow continues to offer a Q-absorb line featuring ubiquinone. Both variants of CoQ10 rely on an all-natural, liposome-based delivery system to improve absorption. According to Jarrow, “This delivery system has been validated in multiple trials to significantly improve CoQ10 absorption over powdered CoQ10 dosage forms.”
CoQ10 is also a feature product for ZMC-USA LLC (The Woodlands, TX). Some six years ago, in 2005, ZMC-USA and its parent company ZMC began offering the first non-Japanese fermented CoQ10. The firm’s aim, says Scott Steinford, president of the U.S. operation, was to relieve some of the price pressures then associated with CoQ10. These price pressures resulted from a spike in demand starting in 2003 and were not eased until new sources of supply came on stream about four years later.
Blue California’s (Rancho Santa Margarita, CA) contribution to heart health is vitamin K2. Cecilia McCollum, executive vice president, says that vitamin K2 “removes the calcium from the arteries and delivers it to the bones where it is used in the production of new bone cells.” She cites research indicating that the nutrient can reduce arterial calcification by as much as 37%.
Sadly, cardiovascular deficiency will continue to be “good news” for suppliers of heart-health supplements.
“More than 91.3 million Americans are over the age of 50 and have consumed a lifetime of fat-enriched foods, leading to the highest incidence of obesity in the country’s history,” says Tom Morse of Telos Ceuticals. To this, he adds the proliferation of western fast food globally, in countries such as China and India, and he concludes, “The demand for products that can improve cardiovascular health continues to grow exponentially.”
Cognis’s Laura Troha remarks, “Aging boomers are increasingly interested in health maintenance, including heart protection. Specifically, those with a family history of high cholesterol and heart disease are looking for options that will ensure a future of good health. And they know most diets just don’t measure up. So, dietary supplements and functional foods with omega-3s and sterols can help bridge the nutritional gap.”
“As we all know,” says Elzaphan Hotam
of Enzymotec USA, “Lovaza, a high-potency fish oil, has been a very successful drug product for reducing triglycerides during the past few years.” Its sales are equal to the whole nutraceutical omega-3 category, he estimates, noting, “We ourselves have started promoting our version of sterol–omega-3 through the practitioner community.”
Don’t expect to see either the need for or the presence of heart-health supplements to disappear-or even lessen-in the foreseeable future. More’s the pity.