Heart-Healthy Formulating
January 19, 2011 - Article
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By Donna Berry, Contributing Editor

He accepted an early retirement and was able to live comfortably on a government pension. Married with no kids, he stayed busy and stress-free by volunteering as a tutor, reviewing journal articles and meeting weekly for decaf coffee with other recent retirees in his specialized mathematical field. Daily walks, runs or bike rides complemented frequent tennis games and the occasional shooting of hoops. He adhered to a healthy diet and even calculated his sodium intake to ensure it did not exceed the recommendations for his age, which was 61 years and two days the morning he died instantly after a massive heart attack.

Sadly, my brother believed he was doing all the right things for optimum heart health, yet he still succumbed to America’s No. 1 killer, as genetics plays a major role. Still, it’s no wonder that heart health is one of the most-desired and highly demanded health benefits from functional foods, according to “Functional Foods and Drinks: A Global Strategic Business Report" from Global Industry Analysts Inc., San Jose, CA.

“Heart health is a key driver of many of today’s buying decisions," says Carol Lowry, applications scientist, Cargill Health & Nutrition, Minneapolis. However, consumers are learning not to believe all the health and nutrition messages that have been circulating―pardon the pun―and are becoming more discriminating with their food purchases. This presents an opportunity for manufacturers willing to invest in ingredients that have been clinically proven to assist with heart health.

Heart-health foods can be either “minus" or “plus" products—or even both. Minus refers to the absence or reduction of ingredients or food components that have a negative correlation to heart health, while plus products are those foods that contain ingredients or components that have been shown to positively impact the heart.

Interestingly, according to data from a consumer survey included in “Reimagining Health + Wellness 2010" from The Hartman Group, Bellevue, WA, consumers are more apt to see foods as useful in preventing rather than treating health problems. For example, 56% of respondents said they are using foods to prevent high cholesterol, as compared to 30% using foods to treat it. And when asked how they would describe themselves based on a number of statements about shopping for foods and beverages, 29% of respondents selected “I look for foods and beverages that are good for my heart."

Claiming to be heart healthy

What defines a food or beverage as being “good for the heart"? FDA assists in this area, as the agency has approved a number of health claims—those that meet significant scientific agreement (SSA), as well as those described as qualified—linking consumption of specific foods or food ingredients to reducing one’s risk of developing coronary heart disease (CHD), the most-common and serious form of cardiovascular disease (CVD), which includes diseases of the heart and circulatory system, such as heart attack and stroke.

In order for a food to make any of these heart-health claims, it must meet the nutrient content requirements of Title 21 of the Code of Federal Regulations (CFR), Part 101, Section 62 for a “low-saturated-fat," “low-cholesterol" and “low-fat" food. In fact, if a food meets these requirements, it typically qualifies for the SSA claim (21 CFR 101.75) that reads: “Diets low in saturated fat, cholesterol and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood low-density lipoprotein (LDL) cholesterol levels and physical inactivity." There are a number of approved verbiage variations to this claim.

Another minus SSA claim (21 CFR 101.74) indirectly associated with heart health has to do with sodium and hypertension, also known as high blood pressure, and a recognized risk factor for CVD. Suggested verbiage for the claim is, “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors." To make this claim, the food must meet all of the nutrient content requirements for a “low-sodium" food.

The cholesterol connection

Then there’s also the serum, or blood, cholesterol connection to heart health, which is how a number of other health claims came to fruition, as scientists have an improved understanding of cholesterol and its function in the body.

Cholesterol, a soft, waxy substance found in the bloodstream and an essential component of cell membranes, assists in various biological functions. There are two basic types of cholesterol—high-density lipoprotein (HDL) and LDL—both of which are made by the body and obtained via the diet. When LDL cholesterol circulates in abundance in the bloodstream, it can clog arteries, increasing risk for CVD. HDL helps keep LDL from getting lodged into artery walls.

Recently, scientists identified a number of other “bad" cholesterol molecules, including very low-density lipoprotein (VLDL) and intermediate-density lipoprotein (IDL). To take these into account, medical authorities and researchers have started referring to a new measurement, non-HDL cholesterol, which is basically total cholesterol minus HDL. This is important, because scientists now believe that a healthy level of HDL may also protect against CVD, while low levels have actually been shown to increase risk.

“Non-HDL cholesterol has been shown to be a somewhat stronger predictor of CVD and mortality risk than LDL cholesterol in population studies," says Elaine Krul, nutrition discovery lead, Solae LLC, St. Louis. “Non-HDL cholesterol represents the total amount of cholesterol carried in particles in blood associated with the highest risk of developing atherosclerotic plaque in the blood vessels. Therefore, it is not surprising that more and more physicians are seeking ways to reduce non-HDL cholesterol beyond just lowering LDL cholesterol as a means to reduce cardiovascular risk in their patients." Diet is one of those ways.

Why is this important to formulators? A number of food ingredients have been shown to decrease non-HDL and total cholesterol while not impacting the “good" cholesterol, or HDL. So, while a low-cholesterol food is attractive to consumers with heart health on the top of mind, a non-HDL-reduction promise may prove more appealing.

Fiber’s fame

A number of fiber ingredients have been shown to do just that. There are two SSA claims regarding fiber intake and decreased risk of heart disease. And for good reason, years of research and clinical trials support many heart-healthy benefits of consuming fiber, in particular soluble fiber.

“Fiber can protect against CHD by lowering LDL blood cholesterol, attenuating blood triglyceride levels, decreasing hypertension and normalizing post-prandial blood glucose levels," says Ram Chaudhari, senior executive vice president and chief scientific officer, Fortitech Inc., Schenectady, NY. “The consumption of dietary fiber, especially water-soluble fiber, is inversely associated with CHD risk."

The first fiber claim (21 CFR 101.77) is exclusive to fruits, vegetables and grain-based foods that naturally contain soluble fiber, specifically at least 0.6 grams per reference amount customarily consumed (RACC). The second claim (21 CFR 101.81) also focuses on soluble fibers, specific types that can be inherently present in foods or are added to foods. The latter represents one of the greatest opportunities in heart-healthy formulating.

To make the claim, the food product must include one or more of the following: oat bran, rolled oats, whole oat flour, whole grain barley or dry milled barley, and the whole oat or barley foods must contain at least 0.75 grams of soluble fiber per RACC of the food product; oatrim (the soluble fraction of alpha-amylase-hydrolyzed oat bran or whole oat) or barley betafiber (the ethanol precipitated soluble fraction of cellulase- and alpha-amylase-hydrolyzed whole grain barley) that contains at least 0.75 grams of beta-glucan soluble fiber per RACC of the food product; or psyllium husk that contains at least 1.70 grams of soluble fiber per RACC of food product. The amount of soluble fiber per RACC must be declared on nutrition labels.

Whole grains are typically higher in fiber, vitamins and minerals, and antioxidants. All of these components are believed to provide cardiovascular disease benefits. “Increasing daily fiber intake from whole grains, fruits and vegetables can positively impact heart health," says Elizabeth Arndt, director of research & development, ConAgra Mills, Omaha, NE. “Research has shown that eating three servings of whole grains per day, as part of an overall healthy diet, may reduce the risk of CHD, diabetes and certain cancers, and may help maintain weight."

Specialized grains and ingredients can increase the content of certain beneficial components. For example, Arndt notes that ConAgra Mills offers a proprietary high-fiber whole grain that is “available in flour and flakes. It is an all-natural, proprietary type of barley that has at least 30% fiber, which is three times more fiber than oats, giving it the highest fiber content of any commercially available whole grain. At least 40% of this fiber is present as beta-glucan soluble fiber, which makes it a powerful ingredient for heart health. Because of its concentrated fiber, you don’t need to add much to a formula to get a nutritional boost. Work we’ve done in our research labs and test kitchens, along with feedback from customers, has shown that it can successfully increase the levels of fiber, not to mention other whole-grain nutrients, in many popular foods, such as pizza crusts, tortillas, cereals, granolas, cookies, muffins, meat systems, fillings and side dishes, while enhancing flavor, texture and appearance."

Soy protein shines

Soy protein is another cholesterol-reducing nutrient recognized by formulators. An SSA claim (21 CFR 101.82) allows for the following on qualified foods: “Diets low in saturated fat and cholesterol that includes 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides __ grams of soy protein."

Soy protein’s ability to lower total and LDL cholesterol has been extensively studied, but the mechanism whereby soy protein lowers cholesterol remains unresolved. However, according to a new study published in the Nov. 2010 issue of Journal of Clinical Lipidology (4(6):531-542), soy protein was shown to lower total cholesterol and non-HDL cholesterol significantly more than milk protein in patients with moderately high cholesterol levels.

“The results also showed that soy protein lowered non-HDL through a mechanism that does not involve increased bile acid excretion, but some yet-to-be-determined mechanism," according to

Kevin Maki, president and chief science officer, Provident Clinical Research & Consulting Inc., Glen Ellyn, IL, and lead author of the study.

The study evaluated the effects of an insoluble fraction of soy protein, compared to total milk proteins with high-calcium content, on the fasting lipid profile. The soy protein used was a relatively insoluble fraction of soy protein isolate that had been shown to lower plasma cholesterol and increase fecal bile acid excretion in animals. The levels of isoflavones in the soy protein were lower than the average commercial soy protein isolate, further supporting the notion that isoflavones do not play a role in the cholesterol lowering.

“The fact that soy protein significantly decreased non-HDL cholesterol levels compared to milk protein in this study is very promising," says Elaine Krul, co-author of the study and nutrition discovery lead, Solae. The milk-protein-supplemented group did show modest cholesterol lowering.

Sterols and stanols

The final SSA claim for CHD (21 CFR 101.83) pertains to diets that include plant sterols and stanol esters. The claim currently is for food products that contain at least 0.65 grams of plant sterol esters or at least 1.70 grams of plant stanol esters per RACC. Two servings of such a food eaten at different times of day and with other foods has been shown to reduce the risk of CHD by lowering blood cholesterol levels.

Plant sterol or stanol esters, collectively often referred to as phytosterols, have been esterified by creating an ester bond between a fatty acid and the sterol or stanol. Esterification occurs in intestinal cells and is also an industrial process, which makes the sterols and stanols more fat-soluble so they can be easily incorporated into fat-containing foods.

In early Dec. 2010, FDA published a proposal to amend the SSA claim. The amendment would allow the claim to extend to nonesterified sterols and stanols and to include a broader range of food applications. (The original GRAS notification was for spreads and dressings, then expanded to juice, milk, yogurt, bars, coffee and tea.) Further, the claim would be modified for the daily dietary intake of the substance specified in the claim as necessary for the claimed benefit and by adjusting the minimum amount of the substance required for a food to bear the claim.

This proposed amendment comes after numerous clinical trials have reported that daily consumption of 1.5 to 3.0 grams of phytosterols from foods can reduce total cholesterol levels by 8% to 17%. FDA states in the proposal, “Based on the scientific evidence regarding the relationship of consuming phytosterols with a reduced risk of CHD, FDA tentatively concludes that 2 grams of phytosterols per day is the daily dietary intake necessary to achieve the claimed effect."

Lowry says: “Plant sterols are no longer a novelty ingredient. Our consumer research shows that there has been a 65% increase in public awareness of plant sterols and their heart-health connection."

A number of formulating options for sterols exist, including water-dispersible and fat-soluble ingredients. “Our plant sterol ingredients do not impact taste or texture and are currently used in juice-based drinks, juice-milk beverages, breakfast cereals, nutritional bars and yogurt," says Lowry.

J. J. Mathieu, technical services, ADM, Decatur, IL, says “Nonesterified phytosterols have application in ready-to-eat breakfast cereals, pasta and noodles, baked foods and salty snacks," he says. “There’s also a version that has been micronized for applications where fine texture is critical.We have esterified phytosterol products for vegetable-oil-based applications, such as vegetable-oil spreads, and dressings for salads and mayonnaise, but also in water-based systems that include protein, such as yogurt-type products and dairy analogues, including soymilk, cream substitutes and frozen novelties."

Qualified claims

A number of foods and food ingredients are linked to a qualified heart-health claim. Many qualify based on their unsaturated-fatty-acid profile and low levels of non-HDL cholesterol. These include select tree nuts, the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), monounsaturated fatty acids from olive oil, unsaturated fatty acids from canola oil, and corn oil.

“The benefits of omega-3s appear to be due to improvements of the ratio of HDL to non-HDL cholesterol, lower levels of plasma triglycerides and the anti-platelet and/or anti-arrhythmic effects of these fatty acids," says Chaudhari. “In addition, there is some suggestion that DHA may also reduce blood levels of C-reactive protein, a biomarker of inflammation."

On the horizon

There are a number of other foods recognized for their heart-healthfulness. The list includes dark chocolate, green tea and red wine, all of which can be concentrated sources of bioactive antioxidants shown to help protect blood vessels surrounding the heart muscle. None of these products can explicitly make any heart-health claims … yet.

Scientists are aggressively documenting the clinical benefits of many antioxidant-rich foods. For example, a study published online in Nutrition, Metabolism & Cardiovascular Diseases (doi:10.1016/j.numecd.2010.03.003) is the first published human study to positively link resveratrol (the antioxidant found in red wine) to improved cardiovascular health. Specifically, the study demonstrates that resveratrol is effective in improving flow-mediated dilation in humans, a biomarker linked to the healthy functioning of the cardiovascular system.

The double-blind, placebo-controlled trial used various levels of high-purity resveratrol from DSM Nutritional Products Inc., Parsippany, NJ, which is now involved with five ongoing human studies for high-purity resveratrol, and that list grows with each passing month, notes Frank DeJianne, global business manager. “We’re working with top researchers from around the world in the areas of cardiovascular health, metabolism, cognitive and physical performance," he says.

Researchers will continue to explore the components of food, while chemists will try to isolate heart-healthy ingredients. This is all in order to provide formulators with the tools to develop products that keep the heart in tick-tock shape.

Donna Berry, president of Chicago-based Dairy & Food Communications, Inc., has been writing about product development and marketing for 13 years. Prior to that, she worked for Kraft Foods in the natural-cheese division. She has a B.S. in food science from the University of Illinois in Urbana-Champaign. She can be reached at donnaberry@dairy-food.com.

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