Food Product Design: Cover - April 2004 - Mainstreaming Functional Foods

April 2004

Mainstreaming Functional Foods

By Angela M. Miraglio, R.D.Contributing Editor

The amorphous functional food category continues to grow and mature despite a lack of regulatory definition and consumer acceptance of its name or its synonym, nutraceuticals. However, a marketplace with a multitude of value-added foods and beverages oriented toward health is a natural consequence of the advances in food and public health policy of the last century. For years, consumers were primed to accept foods with extra nutrients, such as vitamin D-fortified milk and enriched bread, as "good for you." Therefore, the concept of foods providing more than pleasure and inherent nutrients isn't a stretch for the baby boomer who wants to ward off the effects of aging, the senior citizen who wants to circumvent costly health care and prescription drugs, and the younger consumer who wants to achieve high performance. Once consumers become familiar with and accept health-promoting substances in a dietary supplement form, like pills, it seems like an easy move to migrate it into a nutritional food or beverage, according to Steve Snyder, vice president of sales and marketing, Cargill Health & Food Technologies (HFT), Minneapolis.

A number of health-promotion and disease-prevention platforms exist today with many successful products. Dairy products and calcium-fortified beverages address bone health and osteoporosis issues while fat-modified, fiber-enhanced, and sterol- and stanol-fortified products address heart-disease concerns. The inclusion of pre- and probiotics in various foods promotes intestinal health. For the athlete or older adult who wants to continue an active lifestyle, energy drinks and bars can be picked up at the local supermarket. And products that modify glycemic response, originally targeted only to people with diabetes, have found a new market in the weight-conscious population.

Laying the foundation While numerous studies on the potential health benefits from a food or component in foods appear each month, many only suggest the what, why and how of efficacy that is elemental to developing and marketing functional foods. Such murky waters make it difficult for food scientists and marketers to see clearly enough to develop products that meet consumer needs and expectations. A successful functional food or beverage must contain at least one active component with a proven benefit in a delivery system that appeals to consumers in its form, taste and price. This it true regardless of whether the intended market is mainstream or niche. Proposed changes to regulatory procedures for health-claim approvals may soon offer more opportunities for new functional foods that utilize ingredients and technologies that are based on good nutrition research and food science.

Ram Chaudhari, Ph.D., executive vice president of research and development, Fortitech, Inc., Schenectady, NY, formulates premixes and nutrient systems for a variety of functional foods, beverages and supplements. He cites low-carbohydrate and low-glycemic foods, fortified waters and functional beverages as hot product-development areas, along with a lot of interest in omega-3 fatty acids, isoflavones, pre- and probiotics and lycopene ingredients. In choosing functional ingredients and botanicals, he says that safety and efficacy are always important, as is a good understanding of the reactions that occur during processing and shelf life. He adds that there is much confusion and a need to do more research, especially with botanicals, and observes that large scientific companies are doing the majority of the work.

Ingredient companies tend to focus on studying the active components they sell, not necessarily finished products. Snyder says: "Cargill HFT is open to and does do cosponsored clinical research with customers. However, oftentimes major consumer companies prefer to do their own research in support of their advertising claims." He sees a developing trend where there is not only a solid core of science on each ingredient but also the ability to modify and migrate it across applications. For example, Cargill HFT's CoroWise(TM) plant sterols were originally developed for use in fat-based systems, like spreads and salad dressings, but then were modified to work in water-based systems, such as orange juice.

Most new functional foods rely on data from animal and clinical studies to support the efficacy of the active compound but only occasionally obtain data on the retail product itself. Minute Maid® Heart Wise(TM) orange juice, from the Coca-Cola Company, Atlanta, fortified with Cargill HFT's plant sterols, was recently investigated in a clinical study conducted at the University of California, Davis, School of Medicine and Medical Center, and supported by a grant from National Institutes of Health, Bethesda, Maryland, and the Minute Maid/Coca-Cola Company. The study measured the effect on blood lipid levels in healthy volunteers with mildly elevated cholesterol levels from consuming a glass of sterol-fortified orange juice vs. ordinary orange juice twice a day as part of a normal diet. Results demonstrated a lowering of the "bad" cholesterol for the test group compared to baseline and the control group. Not only does this research show consumers that the product does what it is supposed to do, but it also shows them how easy it is to do it. Ideally, all functional foods and beverages should have the same level of clinical studies to back them up.

As more details about the diet-health connection unfold from animal and clinical studies, food scientists in industry and academia search for new ingredient sources, forms and applications. A number of well-researched ingredients and technologies designed to meet the taste/efficacy/price challenge are now reaching the marketplace. Some are refinements and expansions of existing functional ingredients while others are totally new -- and all hold promise to add ingredient and/or nutritional functionality to foods and beverages.

Neutralizing radicals Several different types of compounds exhibit antioxidant activity, which many experts believe help protect against oxidative damage that may lead to many chronic diseases. As clinical research continues to expand the list of potentially beneficial substances, it also exposes some inconsistencies in commonly perceived benefits. For example, recent research indicates that a diet rich in vitamin E and certain carotenoids may prevent type 2 diabetes while two other studies call into question vitamin E's efficacy in preventing heart disease and cancer. Other studies on the role of beta-carotene in preventing cardiovascular disease yield contradictory findings. Frequently, compounds appear to be most effective when consumed in their natural state as part of a food, as reported in some studies on lycopene. Thus, when formulating functional foods and beverages with antioxidants, clinical research that supports health claims for the actual product being offered seems prudent.

Antioxidants are widely available in dietary supplement forms and many of these ingredients are moving into the functional food arena. Ellen Schutt, marketing director, RFI Ingredients, Blauvelt, NY, says that a number of dietary supplement and mainstream food companies have shown interest in their natural ingredients and a new product introduction from Fuze Beverage, Englewood Cliffs, NJ, which contains a white-tea blend from RFI Ingredients. GRAS extracts from botanical sources, such as white and green tea, apple, pomegranate, red wine, and rosemary, provide concentrated antioxidant activity measured in oxygen radical absorbance capacity (ORAC) units for RFI's OxyPhyte(TM) line of natural antioxidants. However, she notes that clinical support for the potential health benefits only exists for the ingredients themselves rather than the specific product. "One exception is our OxyPhyte Ultra Blend, which was the subject of a human bioavailability study. This proves the product increases antioxidant activity in human plasma," she says. In the study, blood ORAC values measured before and 30 to 60 minutes after a 400-mg dose (5,000 ORAC units) showed an average increase of 12%. This is comparable to increases seen with diets rich in fruits and vegetables.

Schutt says, "Basically, we advise customers on usage based on the ORAC equivalent of a serving of vegetables. This amount varies according to the particular OxyPhyte product used and does not vary by application, although it's much more feasible to put the equivalent of five servings of into a capsule for a dietary supplement application rather than a food item simply due to taste and cost issues." With products only needing 0.20 to 0.42 ml of a liquid ingredient or 62 to 200 mg of a powder to get 800 ORAC units per serving, these functional additives represent an economical, concentrated source of antioxidants for enriching a variety of products.

Another antioxidant entry from the dietary supplement world is Pycnogenol® brand French maritime pine bark extract from Horphag Research, Geneva, and marketed in the United States by Natural Health Science Inc., Hillside, NJ. This natural extract contains a unique combination of bioflavonoids and procyanidins. With an extensive database of research to support its efficacy and safety, this ingredient was self-affirmed as GRAS in May 2003. According to Frank Schonlau, Ph.D., director of scientific communications for Horphag Research, Geneva: "The most prominent application for Pycnogenol is surely the cardiovascular benefit. The fascinating point about Pycnogenol for the cardiovascular system is ... that it acts on the most important risk factors simultaneously. This is why Dr. Ronald Watson called it the 'natural polypill' in a review article, Pycnogenol® and Cardiovascular Health, in Evidence-Based Integrative Medicine, (December 2003: 27-32). It reduces high cholesterol, prevents platelet aggregation and reduces high blood pressure." He adds that the pine bark extract supports the production of nitric oxide in the body and an ideal dosage would be 50 mg once or twice a day.

Recently, a double-blind, placebo-controlled study on hypertensive patients demonstrated that supplementing with Pycnogenol allows a 50% decrease in prescription medication for high blood pressure. Other clinical studies showed improvements in diabetic retinopathy, blood sugar levels in type 2 diabetics, swelling in chronic venous insufficiency, menstrual pain and asthma when used as a supplement, and gingival bleeding when used in a chewing gum. In 2002, researchers at the University of California, Davis, reported a 40% increase in blood ORAC levels after supplementation with the pine bark extract, thus confirming its bioavailability. The product is currently in over 140 dietary supplements, multivitamins and health products worldwide. According to Schonlau, negotiations with interested U.S. companies for use in food products are ongoing. He points to a mineral water in Taiwan and a chewing gum in Europe as examples of successful functional food and beverage products that feature Pycnogenol.

One innovation that can help product formulators increase antioxidant levels in beverages is a new form of vitamin E, according to J.J. Mathieu, technical services manager, ADM, Decatur, IL. "Our Vitamin E 230 Clear was formulated for use in clear beverages. Unlike vitamin C, vitamin E is insoluble in water. It can be dispersed in water but only to yield an opalescent dispersion ... The vitamin E in 230 Clear is nanoemulsified. As a result, the insoluble vitamin E droplets are too small -- smaller than the wavelengths of light -- to scatter and reflect light. The resulting dispersion is crystal clear." The product "is unique in that it can be used to deliver a full 100% of the Daily Value (DV; i.e., 30 International Units) for vitamin E in, for instance, an 8-oz. portion of pure water, without affecting clarity or transparency. Adding 131 mg of 230 Clear to an 8-oz. portion provides 100% of the DV for vitamin E."

This 100% water-dispersible vitamin E is extracted from vegetable oils, a natural, rather than petrochemical, source. "There is definitively a nutritional advantage to natural-source vitamin E. In nature, vitamin E, alpha-tocopherol, exists only as one isomer and, when used in foods or dietary supplements, it is labeled as d-alpha-tocopherol. Research indicates that the human body prefers the natural-source vitamin E over the synthetic forms," Mathieu says. "Moreover, based on the Food and Nutrition Board Expert Panel report on vitamin E, d-alpha-tocopherol has twice the activity of synthetic forms ."

Benefiting from fiber Dietary fiber plays many diverse roles in health and understandably so, because dietary fiber is comprised of myriad nondigestible and partially digestible compounds. Strong documentation exists for cardiovascular and gastrointestinal benefits from the consumption of dietary fiber, especially from whole grains, fruits and vegetables. Most fiber ingredients tout their natural roots, whether it's inulin extracted from a chicory plant or corn starch processed to create digestion-resistant starches or maltodextrins.

Oats and their beta-glucan component are well known and widely used for a positive impact on heart health. According to "Lipids Significantly Reduced by Diets Containing Barley in Moderately Hypercholesterolemic Men," in the Journal of the American College of Nutrition (Feb. 2004: 55 - 62),   the soluble-fiber in barley can also reduce cardiovascular risk factors. Barley Betafiber, a new soluble fiber ingredient extracted from barley using a proprietary technology, will be available in the near future from Cargill HFT. "This new fiber ingredient stacks up well in many areas against oats. Its advantages are that it has a high concentration of beta-glucan and therefore, is a cost-effective source of this healthy fiber," Snyder says. "Additionally, it can be used in beverages, unlike oats, which become thick and very viscous in water-based systems."

Digestion-resistant carbohydrates in the form of starches   or   maltodextrin classify as soluble dietary fiber. Different manufacturing procedures and source ingredients result in varying amounts of fiber in these ingredients. To create Fibersol-2 digestion-resistant maltodextrin from ADM and Matsutani Chemical Industry Co., Ltd., Hyogo, Japan, corn starch undergoes heat treatment and enzymatic hydrolysis. This 90% soluble-fiber ingredient works in a wide range of products without impacting color, flavor or texture. Functional characteristics include rapid dispersion, high solubility, clear solutions, stability under virtually all processing conditions, and a lack of flavor and odor, making it an easy-to-use ingredient. As for its health benefits, Deb Erpelding, technical services manager, ADM, says, "Studies indicate that Fibersol-2 helps maintain healthful, regular laxation and helps maintain healthful levels of intestinal microflora." She adds that the product is GRAS as a maltodextrin with no usage limits.

Increasing dairy positives In recent years, mounting scientific data has confirmed what our ancestors knew intuitively: Dairy products are key to a healthful diet. The most recent verification of their value was published in the January 2004 issue of the American Journal of Hypertension. Dr. David A. McCarron, Nutrition Department, University of California, Davis, and Dr. Robert P. Heaney, Osteoporosis Research Center, Creighton University, Omaha, NE, analyzed data from approximately 100 studies to evaluate the potential health and economic impact of increasing calcium intake to recommended levels through dairy foods by assessing the relationship of dietary calcium or dairy-product intake and risk reduction for disease from the last 20 years. Finding strong evidence for a role in reducing the risk of obesity, type 2 diabetes, coronary artery disease, stroke, nephrolithiasis, osteoporosis, colorectal cancer and pregnancy-related complications, they estimated healthcare cost savings of approximately $214 billion over 5 years through disease reduction if consumption of dairy foods, like milk, cheese and yogurt, was increased to three to four servings a day. While calcium is the most-recognized nutrient in dairy products, it is only one of the components found in dairy that contribute to health. Research suggests that the complete dairy nutrient package of high-quality protein, carbohydrates, essential fatty acids, minerals and vitamins is responsible for its proposed role in preventing diseases.

Fermented dairy products can provide beneficial probiotic bacteria, which are an important part of a healthy gut. Now researchers have found a way to up the ante of live bacteria in yogurt by adding a newly recognized prebiotic, acid whey, to products. This byproduct of cottage-cheese manufacturing is usually dried to a powder and used as animal feed and in a few food products like dips, dressing and sauces, or simply handled as a waste product. However, acid whey is rich in nutrients, especially peptides and amino acids.

Rosemont, IL-based Dairy Management Inc.(TM) (DMI) -- the planning and management organization that builds demand for U.S.-produced dairy products on behalf of American dairy producers -- funded research at South Dakota State University, Brookings, that investigated the use of acid whey in yogurt manufacture. Rajiv Dave, associate professor of dairy sciences at the school, says that substituting acid whey powder for some of the nonfat dry milk in yogurt results in shorter fermentation times and higher levels of Lactobacillus acidophilus than control samples. Additionally, the yogurt with acid whey powder maintained a higher bacteria level during refrigeration storage, confirming the prebiotic activity of acid whey powder to stimulate the growth and viability of the bacteria. Dave adds, "Nutritionally, this yogurt has about 15% to 39% more calcium than regular yogurt and a higher-quality protein because there is more whey protein, and whey is a higher-quality protein than the casein from the nonfat dry milk." Sensory testing showed that strawberry-flavored yogurt with 1.9% acid whey powder was equally acceptable to regular and occasional consumers of yogurt as the control yogurt prepared following commercial production procedures.   Similar results were obtained with fluid acid whey. Dave says that the process involves standard technology and could prove beneficial to manufacturers of cottage cheese and yogurt, as well as provide a more-nutritional yogurt with more probiotic bacteria for the consumer.

Expanding the mineral mix Fortification favorites for functional foods include vital minerals, such as calcium and iron. Today, other essential minerals are expanding the mix. Ellis Hogetoorn, senior market development specialist, health and nutrition, Purac America, Inc., Lincolnshire, IL, says that the company "receives a lot of sample requests for potassium and magnesium supplements. Both our potassium and our magnesium supplements have a self-affirmed GRAS status as nutrients in foods, as well as in dietary supplements." She adds that their main advantage is solubility and, therefore, they don't cause precipitation in beverages. Plus, they're milder in taste with a higher mineral content that is more bioavailable than other compounds. Typical applications include beverages and bars.

Potassium (K) plays a number of vital roles in the body and works in tandem with sodium, calcium and magnesium to regulate blood pressure and neuromuscular activity. In fact, a food that contains 10% of the DV for potassium and is low in sodium can make a health claim related to the reduction of high blood pressure and stroke. Hogetoorn says that most manufacturers aim for a minimum of 5% DV in sport beverages and up to 35% DV in functional foods. Frequently, the goal is to achieve a level of 350 mg per serving (10% DV) to qualify as a "good source" of potassium and a health claim. For example, she says, "Pineapple juice contains about 9% of the RDI per serving and it is allowed to enrich pineapple juice with a small amount of K to bump up the content to 10% RDI/serving, (so) the manufacturer can put a label claim on their packaging." She adds that higher than 35% is not necessary or beneficial or economical.

Though recognized as an essential nutrient, magnesium (Mg) does not benefit from the automatic endorsement of an FDA-approved health claim. Hogetoorn observes that manufacturers seem a little hesitant about supplementing foods and beverages with magnesium because they need to rely on the consumer's knowledge of what it can do for them. She says, "Negative factors associated with low Mg intake are: increased feelings of stress, suboptimal bone health, muscle weakness or cramps, and suboptimal carbohydrate metabolism." She also notes that some research shows that physical and environmental stress decreases magnesium levels, which could lead to a deficiency. Thus, individuals who are physically active or emotionally stressed may benefit from extra magnesium in their diets.

New possibilities with soy Soy has the aura of being one of the "good guys" for healthy eating. Ongoing research keeps uncovering new potential benefits and sorting through the potential negatives. While widely studied for its impact on women because of its phytoestrogen content, it appears that soy may also be able to help men. A recent double-blind, placebo-controlled, parallel-group study demonstrated that consuming at least 20 grams of soy protein and isoflavones (at least 80 mg) a day can reduce the risk of cardiovascular disease in middle-age men with high blood pressure and/or cholesterol levels, as reported in the Journal of the American College of Nutrition (Feb. 2004).

Nutrition professionals and food-industry scientists have been beating the drum about the nutritional and health benefits of soy for years. But, while soy-food consumption has increased, most folks don't consume soy products daily or even weekly. A recent product introduction from ADM, NutriSoy® Organic Whole Bean Powder, may help change this. According to Phil Fass, global business manager, dairy & beverage markets, ADM, its big advantage for consumer acceptance is taste. He says: "This product does not have the typical soy flavor, which consumers are not normally fond of. It tastes more like a pleasant grain-like flavor, slightly sweet." Additionally, its microfine texture means no grittiness and a pleasant mouthfeel. From a manufacturing perspective, the microfine particles are dispersible and self-stabilizing in finished products.

This ingredient consists of spray-dried whole beans and retains all its naturally occurring nutrients, including the okara, a rich source of dietary fiber, which is usually discarded during the manufacture of soy ingredients. Fass says that it "can be used to make dairy analogue products as well as many other food products." He says that the product is currently in soymilk, frozen desserts, drink mixes, smoothies and other products. "Usage levels are around 8% to 10% of total formula," says Fass. Potential labeling claims include "organic," "natural" and "soy health," as well as "excellent source of dietary fiber" or "good source of dietary fiber," depending on its usage rate in products.

Finishing touches Many ingredients used for nutritional or health benefit come with taste and stability challenges. The ultimate success of any functional food or beverage relies on its ability to deliver acceptable-tasting product. Donald Wilkes, founder and president, Blue Pacific Flavors, Inc., City of Industry, CA, says: "We have developed a new flavor-masking technology using taste modulators to achieve dramatically improved taste profiles with high vitamin- and protein-based nutrition products. Additionally, our blocking technology helps the stability of the flavor profiles over time. In low-carbohydrate foods that use high-intensity sweeteners, mouthfeel is often lacking. We are working on a number of proprietary natural ingredient technologies that can add the body and structure characteristics to sugar-free or low-sugar formulations."

None of the efforts to create scientifically based, good-tasting functional foods and beverages will count unless the consumer understands the what and why of these new products. Unfortunately, consumer confusion is abundant and health authorities and consumer advocates are calling for someone to put the E back into NLEA (Nutrition Labeling and Education Act) implementation.

Wilkes thinks he has found the answer to increasing food literacy. He proposes a cooperative, self-regulatory model   based on a variation of FOSHU seal-of-approval (foods for specific health use) in Japan. The Fortifoods(TM) seal-of-approval would certify products that meet standards for healthy food platforms. "A scientific advisory board composed of academia, industry and government agency representatives would define scientific criteria for health and wellness products. Functional foods that pass a review by the board will earn the 'Fortifoods' certification and can use its logo. It's not about health claims but about healthy foods," says Wilkes. The logo would provide the average consumer with the ability to differentiate between foods that are validated as nutritionally healthy compared to conventional foods that are not validated by any third party. The consumer can trust the food that they are purchasing as "healthy" while they may have limited comprehension of the product's nutritional label. The logo will not make any FDA or USDA regulated health claims. He compares the branded, licensed logo to the food equivalent of the "Good Housekeeping Seal of Approval." To maintain third party credibility, he believes that this organization needs to be a nonprofit corporation and says that excess funds from fees would go to state-level consumer education programs that will focus on improving nutrition and exercise literacy for both children and aging Americans.

As the general public internalizes more about the diverse merits of functional foods and the recent advances made in this sector of the food industry, efficacious functional foods will likely become as commonplace as today's fortified foods. Knowledge, after all, is half the battle.

Angela M. Miraglio, M.S., R.D., is a Fellow of the American Dietetic Association from Des Plaines, IL. She has extensive experience in trade communications, public and consumer affairs and technical communications, as well as product development and nutritional assessment. Her firm, AMM Food & Nutrition Consulting, provides food and nutrition communications and technical-support services to food and beverage companies and trade and professional associations. She can be reached at [email protected] .

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