According to the center for Disease Control (February 9, 2010), “approximately one in every six adults— 17 percent of the U.S. adult population—has high blood cholesterol.”

Because of heightened consumer awareness due to the inundation of the marketing of statins by the major pharmaceutical markets, according to Mike Uckele, CN, CEO Uckele Health & Nutrition (Blissfield, MI), the demand for cholesterol control supplements is also very high. “[Statins] have become the top selling prescribed medication in the world.However, it’s now being understood that targeted nutritional support works well to maintain healthier cholesterol levels, along with a healthy diet.”

Uckele’s Chief Science Officer Jack Grogan, CN, said the market has become more interested in natural methods of balancing cholesterol since studies have shown that statin medications can deplete CoQ10, which has shown to be critical in maintaining normal energy production in the heart muscle. “They’re looking for methods to balance cholesterol that will not deplete other necessary cardiovascular support,” he said.

The future of the category lies in recent scientific studies that point to the importance of balancing the ratios of the different forms of cholesterol, rather than simply lowering cholesterol levels. “In the past, the emphasis of the discussion about maintaining healthy cholesterol levels was based on simply Lowering the total and LDL cholesterol values,” Uckele said. “Also, triglycerides are now deservedly getting more acknowledgement in the role that they play as a major risk factor for health issues independently of the cholesterol values, as well as their relationship to healthy HDL and LDL cholesterol levels.” 

Drugs and Alternatives

Steve Holtby, president and CEO of Soft Gel Technologies, Inc. (Los Angeles, CA), noted that many people are familiar with the terms “bad cholesterol” and “good cholesterol,” and correctly think of them as being related to heart disease risk.“Triglycerides are another type of fat in the blood. It is associated with fat from foods, such as animal fats, and can be stored in cells to use for energy,” he said.“Similar to high ‘bad cholesterol’ (LDL) and low ‘good cholesterol’ (HDL), current research reveals elevated triglycerides may contribute to hardening the artery wall, which increases risk for stroke, heart attack and heart disease. High triglycerides should be viewed as a danger signal, as they are often associated with low levels of HDL cholesterol and indicate a problem that causes the body to carry fat particles in the blood that do cause vascular disease.Very high levels of triglycerides can also cause pancreatitis, an inflamed pancreas.”

Though some scientists believe they are overused, there is a place for statin drugs. David Peters, director of sales and marketing with Biovelop AB (Kimstad, Sweden), pointed out that the national institute For Health and Clinical Excellence (NICE) recommends that those patients with a significantly above-average chance of suffering a heart attack, stroke or heart disease over the next 10 years should be prescribed statins. “However, the case for those at lower risk or with only slightly elevated cholesterol levels is far less clear-cut, and in the light of the negative press around statins, it is not surprising to find that these individuals are increasingly looking to alternative, more natural ways of lowering their cholesterol,” he said. “This represents a great opportunity for food and drink manufacturers to create functional products from natural ingredients which target cholesterol reduction as part of a healthy diet and lifestyle.

“Some patients will continue to require statins to reduce the risk of future heart-related health issues, but many could reduce their cholesterol to—and maintain it at—normal levels by incorporating the power of nature into their diets,” Peters added. “Faced with increasing pressure from government to produce healthier foods, the food and drink industry has an ideal opportunity to demonstrate that nutraceutical ingredients can mean healthier sales figures as well as healthier consumers.”

Natural Ingredients & Product Offerings 

Cholesterol lowering supplements, such as red yeast rice, phytosterols, policosanol, guggul, polymethoxylated flavones and tocotrienols, help prevent atherosclerosis and associated diseases. “Too much cholesterol in the bloodstream leads to narrowing and blockage of the arteries that greatly increases the risk of stroke, coronary heart disease and heart attacks,” said Holtby. “Additionally, vitamins C and E, niacin and grape seed extract—all of which are believed to have a dilating effect on blood vessels—may help to get the blood flowing. Certain niacin forms may cause uncomfortable flushing.
Magnesium supplements may help dilate vessels and alleviate arterial spasms.
Omega-3 fatty acids have been shown to decrease high blood triglyceride (fat) levels.”

Having moved beyond commodity ingredients, many suppliers favor branded offerings to address cholesterol that are backed by science. One such product by Soft Gel is Sytrinol®, a patented formulation consisting of palm fruit and citrus extracts that contain polymethoxylated flavones and tocotrienols, and has been clinically proven to help maintain healthy cholesterol levels. “People now have a natural dietary supplement that has been shown in multiple clinical studies to lower total cholesterol, LDL cholesterol and triglyceride levels,” said Holtby. In a clinical trial, soft gels manufactured by Soft Gel Technologies, Inc. exhibited enhanced bioavailability of the key active ingredients found in Sytrinol—specifically, the two polymethoxylated flavones (PMFs) tangeretin and nobiletin. Compared to powder-filled, two-piece hard shell capsules, the soft gel form of Sytrinol was four times more bioavailable.

Sytrinol was shown in several clinical trials to lower total cholesterol by 20 percent, LDL-cholesterol by 22 percent and triglycerides by 28 percent. PMFs modulate lipoprotein and lipid metabolism directly in the liver by decreasing apoprotein B needed for endogenous synthesis of LD-cholesterol, and by inducing the suppression of diacylglycerol acyltransferase—an enzyme required for triglycerides synthesis.

Oat beta glucan is one of the very few ingredients approved by EFSA (European Food Safety Authority), Health Canada and the FDA for cholesterol-reduction health claim purposes, Biovelop AB’s Peters pointed out. “It is the backing of these substantiated health claims that gives the consumer the confidence to purchase products containing it,” he said.

The company’s PromOat™ is an oat beta glucan-rich, soluble fiber ingredient produced in Sweden using locally grown, non-GMO oats. PromOat is naturally separated from the oat bran using a patented, chemical-free technology, and can be added to a wide range of food, drinks and nutritional supplements to Bestow the health benefits of oats on those products without the taste, color or graininess usually associated with oats.

W. H. Leong, vice president with Carotech Inc. (Edison, NJ), said the company’s Tocomin SupraBio® patented and bioenhanced palm tocotrienol complex is the emerging (and synergistic) ingredient for the category. “There is a stark difference between Tocomin SupraBio and any other conventional tocotrienol preparation in that the absorption of tocotrienols from Tocomin SupraBio is guaranteed to be at least 250 percent better for each individual tocotrienol.” Leong noted a recently reported clinical study that showed that when tocotrienol levels in the blood are significantly raised, reduction in total cholesterol and LDL-cholesterol levels is achieved (Functional Foods in Health and Disease, 3, 106-117 (2011)).

Headquartered in Denmark, Danisco Health & Nutrition introduced PinVita™ Phytosterols this year to keep the heart and arteries in shape by lowering the level of unfavorable LDL cholesterol in the blood by reducing cholesterol absorption.

Derived from a natural and sustainable pine source, PinVita is easy to formulate, and provides food manufacturers potential access to a cardiovascular health claim, according to the company. Peter Wisler, Danisco business development director, said, “It is well documented that lowering LDL cholesterol reduces the risk of cardiovascular health conditions. With PinVita, we provide an ingredient that helps reduce that risk and, it is therefore no exaggeration to state that PinVita comes with ‘science at heart.’” 

Gary Walker, president of Sylvan Bio, Inc. (Kittanning, PA), the only U.S. grower of red yeast rice, stressed that ingredients For maintaining healthy cholesterol are not enough; that consumers need to make conscious lifestyle choices: Eating healthy foods such as fresh fruits and vegetables, grains, fish oil and omega-3s, and nuts such as walnuts and almonds; regular exercise; and not smoking. “Smoking weakens the walls of the arteries and makes them more prone to the buildup of cholesterol,” he said.

“We understand that quality and consistency are two very important factors for consumers when faced with making decisions with regards to their health,” Walker added. The company will be introducing its new line, Synergia Wellness, in the first quarter of 2012. The Synergia Wellness Organic red yeast rice is U.S. grown and USDA Certified Organic.It is also a red yeast rice/vegetarian CoQ10 combination product, and a standalone vegetarian CoQ10, Walker noted.
“When we produce red yeast rice, we keep it in its natural state. It appears that the combination, or cocktail, of natural metabolites in red yeast rice works effectively in cholesterol management.”

Another finished product, Uckele’s Lipisterin, has been very well received in the marketplace, according to the company.“This is a balanced formula that includes nutrients, enzymes and plant extracts that can supply factors to directly support the liver’s ability to properly metabolize HDL and LDL cholesterol balance and healthy fat metabolism,” said Grogan. The product includes vitamins C and B5, guggul, red yeast rice, bromelain, taurine, pancreatin, CoQ10, policosanol and octacosanol.

Other Considerations, News 

With regards to government regulations, an FDA mandate, set to go into effect on February 21, 2012, may mean that supplements claiming to reduce cholesterol and That contain free forms of phytosterols will have to be pulled from shelves, Leong pointed out. “The proposed rule would ban cardiovascular disease risk reduction claims on supplements containing non-esterified phytosterols. Esterified phytosterols are not affected.”

Another change is that the blanket fear of high cholesterol has been replaced.
Holtby noted that it is known that as the size of cholesterol particles decreases, the cardiovascular risks increase. “Normal cholesterol results aren’t necessarily reliable measures of risk,” he said. “There are now tests that screen a far broader spectrum of risk factors that show up in the blood. One of the most important metabolic markers is a small, dense form of LDL. Their small size makes it easier to enter the arterial walls, where they can cause damage and create other cardiovascular issues.”

Ultimately, even with new knowledge of heart health, a healthy lifestyle can’t be replaced with pills. “Modern medications have come a long way in helping to control blood cholesterol levels and high blood pressure, but making diet and lifestyle changes, including regular physical activity, are the best way to help prevent heart disease,” stressed Holtby.

“Patients tend not to think about what they eat or maintaining an exercise regime if they are on drug therapy for elevated cholesterol levels, or those who have elevated Risks for heart disease and stroke. Nobody can ‘eat anything they want’ and stay heart healthy, particularly since foods that contain high levels of saturated fat and/or trans fat contribute to high blood cholesterol.”

Science of Note:

NIE asked article participants what studies and research regarding cholesterol was most impactful to them.

Soft Gel’s Holtby: 

Both cholesterol and CoQ10 share a common biosynthetic pathway, which involves the formation of mevalonate compound with the aid of 3-hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase.Inhibition of HMG-CoA reductase by statin drugs at the mevalonate level will inevitably decrease the levels of both cholesterol and CoQ10.Human studies revealed a significant decrease in CoQ10 serum levels as a result of HMG-CoA reductase inhibitor treatment. In a double-blind, randomized clinical trial, hypercholesterolemic patients received either Lovastatin or Pravastatin over a period of 18 weeks. At the end of the study period, the total serum level of CoQ10 declined by about 25 percent in the Lovastatin and Pravastatin groups. (Mortensen SA et al. Dose-related decrease of serum coenzyme Q10 during treatment with HMG-CoA reductase inhibitors. Mol Aspects Med 1997; 18:S137).

Sylvan Bio’s Walker: 

Dr. Becker, a cardiologist affiliated with Chestnut Hill Hospital, University of Pennsylvania School of Medicine in suburban Philadelphia, has conducted some of the most recent studies. One of his studies was published in the Annals of Internal Medicine: “Red Yeast Rice for Dyslipedemia in Statin-Intolerant Patients.”

Carotech’s Leong: 

We have recently completed the largest-ever human clinical trial on tocotrienols—“Neuroprotective and Cardioprotective Effects of Palm Vitamin E Tocotrienols,” in which Tocomin SupraBio was used. The study results are expected to be published soon and preliminary findings are very positive.