Opportunities for Heart-Healthy Food

The food industry has taken heart disease to heart. The numbers show why. Each year, more than $33 billion in medical costs and $9 billion in lost productivity due to heart disease, cancer, stroke and diabetes can be attributed to diet, according to data from the Centers for Disease Control (CDC). Cardiovascular disease (CVD) claims more lives each year than the other four leading causes of death combined. Given the stakes in terms of numbers and costs, concern is high among government and health professionals, and this is reflected in the amount of research and regulatory activity dedicated to heart-disease control.

Product proliferation 

New studies and more allowed health claims in recent years have encouraged a new age in health-related and health-specific foods. The claim on Oatmeal Crisp from General Mills, for example, states that the cereal “contains ingredients that help lower cholesterol and reduce the risk of high blood pressure and stroke.” Post Grape- Nuts®, with its whole-grain wheat and barley, states “lose 10 lbs. the heart-healthy way!” Minute Maid® Premium Heart Wise™ was “clinically proven to help reduce cholesterol, with 1 gram of plant sterols per 8-fl.-oz. serving.” Cocoavia® from Mars Inc., McLean, VA, contains a patented blend of cocoa flavanols and plant sterols.

All this activity has prompted ingredient companies to offer a wider range of heart-healthy ingredients. For example, PMA International, Toronto, Ontario, is distributing Vinefera for Life, a wine flour made from wine grape skins that contains resveratrol, fiber, and omega-3 and omega-6 fatty acids. Companies such as Kerry Americas, Beloit, WI, and Fortitech, Inc., Schenectady, NY, are promoting omega-3 enrobed chocolate bars; bars with beta glucan and selenium; soy beverages; “sterol shots”; high calcium beverages;

multivitamin gummy bears; antioxidant ice cream; fortified gumballs; heart-healthy chocolate clusters with lycopene, coenzyme Q10, vitamins B12 and B6, vitamin C and folic acid; and heart-healthy beverages with the antioxidants beta carotene and lycopene, as well as vitamin E to help neutralize low-density lipoprotein (LDL, or “bad”) cholesterol, magnesium to stabilize heart rhythm, and folic acid to protect the heart from amino acids linked to heart disease.

All these make it easier than ever for consumers to make positive changes to their diets.

View from the AHA 

So, how exactly can diet be changed, and what direction can be given to consumers? What constitutes a “heart-healthy” food? One answer is to look at the “Diet and Lifestyle Recommendations Revision 2006” from the American Heart Association, Dallas. These recommendations can provide a framework for developing heart-healthy food.

Balance caloric intake and physical activity. Product designers should focus on minimizing calories, especially those from less-healthful fats and nutrient devoid sweeteners, without sacrificing quality.

Consume a diet rich in vegetables and fruits. For product developers, fruit and vegetable products or extracts can be used to replace some of the functionality of fats and sugars while also adding important nutrients and antioxidants. More vegetables can be offered as side dishes or even as entrées.

Choose whole-grain, high-fiber foods. Adding fibers can reduce caloric density, but they also promote satiety by slowing gastric emptying. Viscous fibers can also reduce LDL cholesterol. In addition to fiber, whole grains provide antioxidants absent from fruits and vegetables, plus B vitamins, vitamin E, magnesium and iron.

Consume fish, especially oily fish, at least twice a week. Oily, cold-water fish contain high levels of omega-3 fatty acids and can be substituted for other types of meat in main-dish offerings.

Limit intake of saturated and trans fats and cholesterol. Product developers can lower fat levels and replace saturated and high-trans fats with functional alternatives, including unsaturated fats and hydrocolloids.

Minimize intake of beverages and foods with added sugars. Low-digestible carbohydrates, such as polyols (maltitol, maltitol syrups, polyglycitols, xylitol, etc.), and high-intensity sweeteners can replace added sugars (high fructose corn syrup, sucrose and corn syrup).

Choose and prepare foods with little or no salt. In terms of product development, this is sometimes easier said than done, especially when salt adds more than taste, but more alternatives have become available, such as sea salt, with its greater intensity, and a wider range of low-sodium flavor enhancers.

Follow the AHA recommendations when you eat food that is prepared outside of the home; follow the American Medical Association (AMA) 2006 diet and lifestyle recommendations. This is the downfall of many Americans —they do not choose healthy alternatives in foodservice situations. But this also presents a challenge and an opportunity for foodservice operations. Portion sizes must be decreased, and strides can be made toward meeting AHA recommendations without totally eliminating indulgence.

Making claims 

With the AHA recommendations in mind, product designers also need to consider which claims FDA allows for heart-healthy foods. For foods and dietary supplements, FDA recognizes three general categories of claims: health claims, nutrient- content claims, and structure/ function claims. Health claims directly describe the relationship of a food, food component or dietary supplement ingredient and reducing risk of a disease or condition. Nutrient-content claims convey the amount of fat, calories, sugar, sodium, etc., in a product (i.e., “free,” “low” and “reduced”). In general, structure/ function claims describe the role of a nutrient or ingredient on the body’s structure and/or function; for example, “calcium builds strong bones.” FDA has approved 12 health claims to date, six of which are related to heart disease.

Sodium and hypertension (21 CFR 101.74). These products must have low sodium. A potential claim is: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”

Dietary saturated fat and cholesterol and risk of coronary heart disease (21 CFR 101.75). The product must be low in saturated fat and cholesterol, and low fat. The potential claim states: “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.” 

Fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease (21 CFR 101.77). Qualifying products must be a fruit, vegetable or grain product that contains fiber, is low in saturated fat, cholesterol and fat, and must contain at least 0.6 grams of soluble fiber per reference amount customarily consumed (RACC). The label must carry the soluble-fiber content. A potential claim is: “Diets low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.”

Soluble fiber from certain foods and risk of coronary heart disease (21 CFR 101.81). The product must be low in saturated fat, cholesterol and fat, and must contain one of the following: one or more eligible sources of whole oats, adding up to at least 0.75 grams whole oat soluble fiber per RACC in the finished product; psyllium seed husk containing at least 1.7 grams of psyllium husk per RACC; or beta-glucan soluble fiber from oat bran rolled oats, whole oat flour, oatrim or barley.

“The primary health benefit associated with a diet high in beta- glucan from oats (and low in saturated fat and cholesterol) is a reduction in the risk of heart disease,” says Pam Stauffer, marketing programs manager, Cargill Health & Food Technologies, Minneapolis. “Emerging science indicates that barley beta-glucan lowers cholesterol and, thus, may have a similar health benefit.

“In their position statement regarding the health implications of dietary fiber, the American Dietetic Association (ADA), reports that recommended intakes of 20 to 35 grams per day for healthy adults, and age-plus-5 grams per day for children over 2 years old are not being met,” she continues.

“In fact, current estimated consumption rates are 13 to 15 grams per day. The ADA recognizes the health benefits of dietary consumption of viscous fibers as cholesterol- lowering and may also include normalization of blood glucose and insulin levels.”

A suggested claim is: “Soluble fiber from foods such as (name of soluble fiber source and, if desired, name of food product), as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of (name of product) supplies __ grams of the (necessary daily dietary intake for the benefit) soluble fiber from (name of soluble fiber source) necessary per day to have this effect.”

Soy protein and risk of coronary disease (21 CFR 101.82). Products must contain at least 6.25 grams of soy protein per RACC and must be low in saturated fat, cholesterol and fat. The claim reads: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides (list number) grams of soy protein.” Other reported health benefits supported by industry clinical studies include: improved blood lipids, CVD, menopause, cognition; bone calcium loss, positive impact on bone density; renal dysfunction, positive impact on kidney function for diabetics; and structure/function claims for protein and satiety, reduced hunger and/or enhanced satiety, and useful and effective in weight loss.

“Examples of current products and categories that include our range of soy proteins include: nutritional bars, nutritional beverages, juices, soymilk, bakery products, snack products, meat analogue products, frozen meals, frozen desserts, cereals, breakfast foods and side dishes,” says Sarah Mulvihill, commercial director, Kerry Ingredients—Kerry Proteins & Nutritionals. Products include soy powders with approximately 65% protein and 22% fiber—these extrude and puff extremely well and can be textured to mimic the cell structure of most meats. High-protein soy powders ranging from 75% to 80% protein can be customized for different end uses, including beverages, ice cream, smoothies, meat analogues, retort beverages, juice systems, energy bars, cereals, infant and follow-up formulas, baked goods and sauces. Ninety percent protein isolates are utilized primarily in beverages, infant formula and protein crisps. Soymilk powder, with approximately 50% protein, can be used in beverage, pudding, yogurt or milk-replacement applications. All these products are used in foods to make the soy claim.

Plant sterol/stanol esters and risk of coronary heart disease (21 CFR 101.83). Products must contain at least 0.65 grams plant sterol esters per RACC of spreads and salad dressings, snack bars, and dietary supplements, and must be low in saturated fat and cholesterol.

“Sterols and sterol esters rank high in safety and efficacy. Sterols rated No. 1 after we looked at the entire category, including all the cholesterol-targeted ingredients, the levels of clinical support, defined mechanisms of action, and adverse events,” notes Laura Troha, marketing manager, Cognis Nutrition & Health, La Grange, IL. “And FDA recognized this by allowing the sterol heart-health claim that brand marketers have the ability to leverage in their messaging. Regulatory consultants will tell you that few products are qualified to use the cholesterol-reducing claim.”

Stauffer adds: “Clinical studies suggest that plant sterols can reduce cholesterol 8% to 15%. Numerous regulatory authorities, cholesterol-educational coalitions and independent researchers have reviewed the data of numerous clinical studies and have concluded that dietary intake of plant sterols is effective in lowering LDL cholesterol. Phytosterols have been clinically evaluated in many different populations, under different circumstances over the past 50 years, and have consistently demonstrated the ability to reduce blood cholesterol in humans.”

A potential claim is: “Foods containing at least 0.65 grams per serving of vegetable oil sterol esters (or 0.40 grams of plant sterols), eaten twice a day with meals for a daily total intake of at least 1.30 grams (or 0.80 grams of plant sterols), as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving (name of food) supplies __ grams of vegetable oil sterol esters.” Sterol esters and plant sterols are available in several forms—from high-concentration oils to lower-concentration dispersible powders.

In the FDA Modernization Act of 1997 (FDAMA), health claims based on an “authoritative statement” from a scientific body of the U.S. government or the National Academy of Sciences are also allowed. There are three permitted to date.

Whole grain foods and risk of heart disease and certain cancers. The product must contain 51% or more whole-grain ingredients by weight per RACC, must be low fat, and must contain specified dietary fiber content per RACC. The required claim is: “Diets rich in whole grain foods and other plant foods and/or in total fat, saturated fat and cholesterol may reduce the risk of heart disease and some cancers.”

Potassium and the risk of high blood pressure and stroke. Products must be a good source of potassium and must be low in sodium, total fat, saturated fat and cholesterol. The required claim is: “Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke.”

Saturated fat, cholesterol and trans fat, and the risk of heart disease. On Nov. 15, 2006, FDA allowed a new claim for foods low in saturated fat, trans fat and cholesterol. Statements for the claim include: “Consume less than 10% of calories from saturated fatty acids and less than 300 mg per day of cholesterol, and keep trans fatty acid consumption as low as possible” or “High intake of saturated fats, trans fats and cholesterol increases the risk of unhealthy blood lipids levels, which, in turn, may increase the risk of coronary heart disease.”

Claiming qualified success 

One of the more interesting groups of health claims are those within the qualified health claim category. FDA provided for these in 2003 for those foods, ingredients and dietary supplements which have emerging evidence for their effects on disease or healthrelated conditions. For those with enough evidence of efficacy, FDA can write an “enforcement discretion letter” to detail allowed claim statements and conditions that must be met. A number of these are already on file that target hearthealthy foods.

Nuts and heart disease. Products eligible include whole or chopped nuts, nut-containing products, and whole nuts limited to the types of nuts and conditions listed in the docket. The claim allowed is “Scientific evidence suggests but does not prove that eating 1.5 oz. of most nuts (such as name of specific nut) as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease.”

Walnuts and heart disease. This claim is specific to whole and chopped walnuts, and may claim that “Supportive but not conclusive research shows that eating 1.5 oz. per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat (and calorie) content.”

Omega-3 fatty acids and coronary heart disease. This claim refers to conventional foods and dietary supplements that contain long-chain polyunsaturated EPA and DHA omega-3 fatty acids. “The science supporting the heart-health benefits of omega-3s is exploding. In fact, a recent study found that raising the levels of omega-3s fatty acids in the diet may prevent more sudden deaths than automated defibrillators,” says Rob Bailey, marketing manager, Cognis Nutrition & Health. “But, the problem is, the average American does not come close to consuming the amount of omega-3s necessary to achieve the positive results shown in the scientific research.”

The claim may read: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of (name of the food) provides ( ) gram of EPA and DHA fatty acids. (See nutrition information for total fat, saturated fat, and cholesterol content).”

The biggest challenge with incorporating these into foods stems from the reason they provide health benefits—their chemical structure. The unsaturated bonds are just not very stable. According to Patrick Luchsinger, Lipid Nutrition, Channahon, IL: “Microencapsulation powders provide protection from oxidation and premature chemical reactions with other ingredients or the environment. All of our products in either oil or powder forms contain antioxidants to ensure stability.”

B vitamins and vascular disease. This claim refers to dietary supplements containing vitamin B6, B12 and/or folic acid, and states: “As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6 and vitamin B12 may reduce the risk of vascular disease. FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”

Monounsaturated fatty acids from olive oil and coronary heart disease. This claim is restricted to pure olive oil, dressings for salads, vegetable oil spreads, olive oil-containing foods, and shortenings, all of which must contain at least 6 grams of olive oil per RACC and adhere to other stated restrictions. The statement reads: “Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains (X) grams of olive oil.”

Olive oil contains approximately 70% monounsaturates, with about 10% linoleic acid (an omega-6 fatty acid) and about 1% linolenic acid (an omega-3 fatty acid). In addition, one gram of olive oil contains about 0.5 mg of antioxidant polyphenols.

Calcium and hypertension, pregnancy-induced hypertension and preeclampsia. This claim refers to dietary supplements containing calcium, and FDA gives a specifically worded claim for each of the above conditions. The claim for hypertension reads: “Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.” Hypertension can lead to the development of cardiovascular disease. Calcium interacts with other ions (sodium, potassium, magnesium) in affecting blood pressure.

Clearly, the future of functional foods that bring cardiovascular benefits is bright and rapidly expanding.

Ronald C. Deis, Ph.D., is the vice president of technology at SPI Polyols, Inc., New Castle, DE. He has 2 years of experience in the food industry, both in food-ingredient and consumer-product companies, and is an active member in a number of trade associations. He has been a short-course speaker, worked as a freelance writer covering a number of food-science- related subjects in food journals, and contributed chapters on sweeteners and fat replacers for several books.

Beyond the Claims

So far, FDA has denied specific claims related to green tea, eggs with enhanced omega-3 fatty acid content, and vitamin E and heart disease. Denial simply means the available data does not yet support a specific health claim, not that these ingredients have been proven ineffective.

Many other ingredients can be used to provide benefits, including other fibers. According to a study presented at the American Heart Association’s Sixth Annual Conference on Arteriosclerosis, Thrombosis and Vascular Biology in 2005, fiber supplements can lower “bad” low-density lipoprotein (LDL) cholesterol and increase “good” high-density lipoprotein (HDL) cholesterol in people with type 2 diabetes. Study participants consumed beverages with soluble and insoluble fiber from guar gum, gum arabic, locust bean gum, pectin and oat fiber.

Research on mice published in the British Journal of Nutrition suggests that the probiotic fibers inulin and oligofructose can inhibit build-up of fatty deposits in the animals’ arteries. French researchers incorporated three ingredients from Orafti Active Food Ingredients, Malvern, PA, into the mice diets: 10% long-chain inulin (Beneo HP), oligofructose (Beneo P95), or oligofructose- enriched inulin (Beneo Synergy1).

Another fiber worth considering is konjac. “There are many studies showing the health benefits of konjac in reducing cholesterol and lowering glycemic index. Konjac also allows for a feeling of satiety, as it coats the stomach,” says Joshua Brooks, vice president, sales, Gum Technology Corporation, Tucson, AZ.

Another new ingredient that might provide benefits is supplemental chromium. According to Amy Weitz, director of communications, InterHealth Nutraceuticals, Inc., Benicia, CA: “Our product has been shown to be more effective than chromium picolinate in reducing oxidative stress and important biomarkers that lead to vascular inflammation and reduced insulin sensitivity. Other studies have shown that this product may reduce the risk of CVD in people with insulin resistance and diabetes.”

In addition to health claims, nutrient content claims and structure/function claims, developers can seek help from suppliers to identify heart-healthy ingredients in particular applications. “(We) manufacture custom nutrient premixes based on our client’s needs and requirements,” says Mark Fanion, communications manager for Fortitech, Inc. “Our premixes can deliver basic everyday nutrition to health-condition-specific blends. We can formulate a premix that incorporates two nutrients ... or even 75 different nutrients. The sky is the limit when it comes to micronutrient fortification.”