Opinion:

Hype or Hope: What's driving nutraceuticals?
by Clyde E. Stauffer, Ph.D

 
It’s not often that a food industry "buzzword" evolves into a multi-billion dollar industry. But that’s the direction nutraceuticals seem to have taken in recent years.
Having been popular in Europe for years — they are now prescribed by doctors — approximately 40% of the United States population is turning to "alternative products" to treat medical concerns, according to a recent article in The Journal of the American Medical Association. Currently, nutraceutical sales are estimated at $80 billion, according to statistics from the 1997 Nutracon conference, sponsored by Global Business Research Ltd., New York.

But just what are nutraceuticals and what do they mean for the baking industry? Can they really treat or prevent certain diseases, or is it all just marketing hype, as some critics claim?
 The word "nutraceutical" was coined in 1976 by Stephen L. DeFelice, M.D., founder of the Foundation for Innovation in Medicine. The U.S. Dietary Supplement Health and Education Act of 1994 (D.S.H.E.A.), in its proposed guidelines, defined a nutraceutical as "any non-toxic food component that has scientifically proven health benefits, including disease treatment or prevention."
 According to D.S.H.E.A., the functional component of the food must be standardized in the nutraceutical product and produced under good manufacturing practices (GMPs). Once this is accomplished, a label can then be created to describe the "role of this functional food component intended to affect the structure or functions in humans" and characterize "the documented mechanism by which this component acts to maintain such structure or function."  

Nutraceutical proponents insist that D.S.H.E.A. is an effort to make truthful information about these products available to consumers. But critics argue that D.S.H.E.A. promotes false and misleading claims and increases risks to consumers. They also claim D.S.H.E.A. makes it easier for companies to promote products that may not meet the established regulatory definitions of "food" or "drug;" provides greater flexibility on the type of information included on packaging; and widens the definition of "dietary supplement" so that almost any food or food ingredient could be called a supplement.
 Let’s take a closer look at the subject of this great debate. The nutraceuticals family includes herbs, vitamins and minerals. A nutraceutical is not intended to replace a regular food, but rather to supplement the consumer’s dietary intake. It may be marketed in multiple forms but is formulated to provide a significant percentage of the recommended daily intake of several key nutrients.  
Nutraceuticals, also known as functional foods, are meant to be eaten as a part of the regular diet, and contain one or more additional ingredients that impart health benefits above and beyond those of the regular food.

High-fiber bread is an example — the addition of insoluble fiber confers the known benefits of dietary fiber. In such a case, the manufacturer may make a health claim on the label, in accordance with the regulations promulgated by the Food and Drug Administration (see sidebar on page 49). Manufacturers may add a nutraceutical or phytochemical to their product, but they may not make any specific health claim on the label. The material is listed in the ingredients statement and, if appropriate, such as in the case of vitamins and minerals, on the nutritional label. The hope is that through newspaper articles, magazine stories and TV reports, consumers will be made aware of the purported health benefits of the ingredient and will look for it on the supermarket shelf.

 Nutraceuticals may also be referred to as "designer foods," meaning they have been genetically altered to produce a food or food component with a medical or health benefit. An example of a designer food might be the use of specially modified oil that is high in omega-3 fatty acid. Another possibility is the inclusion of a probiotic culture in yogurt, reputed to boost the immune system. The touted benefits of designer foods are that they either counteract health negatives or provide positive benefits.

 PHYTOCHEMICALS. Phytochemicals are specific compounds or groups of compounds found in plant foods that offer health benefits based on nutritional research. Phytochemicals are found in common foods, such as fruits, vegetables, legumes and seeds, and in not so common foods, such as licorice, soy and green tea. Some phytochemicals have been around for many years, such as the carotenes found in yellow vegetables. Others, such as isoflavonoids, have only recently been recognized as having some biochemical activity in humans. Isoflavonoids are sometimes referred to as phyto-estrogens because they appear to have mild estrogenic properties including interfering with cholesterol absorption in the digestive tract. They are found in soybeans and other legumes. In the digestive tract, isoflavonoids are modified to materials that have weak estrogenic activity, and some studies have connected a high level of dietary isoflavonoids with a decreased incidence of breast cancer.  

Research has shown that substituting textured soy protein for red meat lowers serum cholesterol in men with high levels of cholesterol. If purified soy protein was used, the effect was not seen. It is thought that this activity is due to the presence of isoflavonoids in the protein preparations.

 Plant gums are also phytochemicals. The recent official recognition by FDA of soluble oat fiber from whole oats speaks to the health benefits of these materials. While FDA has approved a health claim for oat gum only in the reduction of coronary heart disease (CHD), numerous studies have shown that it can also help control diabetes. Herbal extracts have a long history as traditional home remedies. They have been used to treat a wide range of diseases including stress, depression, poor blood circulation, insomnia, fatigue and general malaise. Some of the more recognizable extracts in this category are gingko biloba, St. Johns Wort and echinacea.  

Antioxidants. Antioxidants are unsaturated molecules, and in foods they are generally found as pigments. The best known of these is beta-carotene, the intensely yellow material often used as a natural food color. Other related materials — collectively known as carotenoid pigments — include alpha carotene, lutein, lycopene, zeaxanthin and capsanthin. Lycopene, the red pigment of tomatoes, has been shown in several studies to have anti-cancer activity. A research study conducted in Germany indicates that lycopene may be more effective in a processed state than in the native, uncooked state (catsup on a hamburger may counteract the carcinogenic benzo-a-pyrenes formed by grilling the meat). And a recent report from Finland indicated that a combination of lycopene and vitamin E reduces the incidence of prostate cancer.

 Antioxidants may also be effective in combining with and neutralizing oxidation products of normal food ingredients such as proteins and fats, which have been implicated in a variety of diseases such as CHD and cancer. These oxidation products are often present in trace amounts as free radicals, which are presumed to initiate the disease process. Antioxidants can short-circuit these free radicals and thus the development of the disease. It should be emphasized that this is only a reasonable hypothesis — antioxidants can be shown to react with free radicals in the test tube, but there is no direct evidence that it actually happens in the digestive tract.

 Another group of antioxidant pigments is the anthocyanins, which contribute to the blue color in many fruits. The United States Department of Agriculture’s Center on Aging, Boston, recently investigated the antioxidant properties of blueberries and put them at the top of its list of 40 fruits, juices and vegetables in antioxidant activity. Blueberries have vitamins C and E and beta-carotene, all of which are antioxidants. In the baking industry, blueberries are used in muffins, bagels and breakfast cereals among other products. Polyphenols are antioxidants that are widely distributed in the plant kingdom. They are present at a high level in wheat bran, tea, coffee, red grapes (and red wine), prunes and raisins. Besides being antioxidants, polyphenols are also anticarcinogens and are reported to have antibacterial and antiviral activity. Research shows that drinking tea lowers blood serum cholesterol levels and improves the HDL/LDL ratio, thus lowering the probability of developing CHD.  

SUPPLEMENTS. Supplements contain one or more nutrients, typically in a rather concentrated form. These can span a wide range of materials, from a single function supplement such as vitamin C or a calcium supplement, to the various multi-vitamin or multi-mineral tablets on store shelves. In addition to dietary supplements, a wide range of botanical extracts and preparations are on the market. The purported contributions of these to health and well being tend to be anecdotal and traditional in nature, rather than based on strict scientific research.

 Vitamins and minerals. The baking industry’s involvement with enrichment spans nearly 60 years, from the issuance of the first enrichment standards in 1941 to the recent addition of folic acid to the list of vitamins and minerals that are added to enriched flour and other cereal products. The term "enrichment" means restoring the level of vitamins and minerals in a food to those approximating the levels found in the unprocessed material.  "Fortification," on the other hand, means increasing the amount of micro-nutrients to a level greater than that found in the unprocessed food. Thus, adding thiamin, niacin, riboflavin and iron to flour is enrichment, while adding folic acid and calcium constitutes fortification. The distinction might be considered academic (the terms are sometimes used interchangeably), except for one thing: a food that is fortified must be "appropriate."

 According to FDA, a "fortified food" is one that would normally be expected to have some level of micro-nutrients, and fortification is only increasing that level. For example, a cereal grain fortified with vitamins and minerals is acceptable, while a fortified jellybean is not. (This argument is sometimes referred to as the "jelly bean rule" in labeling discussions.)
 Vitamins A and B6 have been proposed for addition to baked foods. Vitamin C (ascorbic acid) is frequently added, not for enrichment but for its role as a dough strengthener (oxidant). While iron is the only required enrichment mineral, calcium fortification is allowed. Zinc and magnesium fortification has also been explored, but is not recommended at this time.
 Buckwheat flour contains high levels of vitamins B1 and B2, which, when combined with vitamin E, are effective as a precaution against arteriosclerosis. Buckwheat also contains potassium, magnesium, phosphate and iron, minerals that play a strong role in preventing hypertension and anemia. The flavonoid rutin is also present in buckwheat and is effective in reducing cholesterol levels in the blood and acts as a preventive measure against high blood pressure. In the baking industry, buckwheat flour is used in the production of breakfast cereals, bread products, pasta products, puffed snack foods, cakes, brownies and other sweet goods.

 The vitamin supplement industry provides numerous other vitamins to consumers. Vitamin E is perhaps the largest selling of these. Some studies have concluded that vitamin E, acting as an antioxidant, may play a role in reducing CHD by inhibiting cholesterol oxidation. Sunflower seeds are a good source of dietary fiber and vitamin E. Applications for sunflower seeds in the baking industry include muffins, bagels, multi-grain nut breads, scones, trail mix, granola bars, crackers and candy bars. Vitamins B6 and B12 are also widely available. Vitamin K, which helps blood clot, is sometimes used by patients with hemorrhagic problems. Coenzyme Q, or ubiquinone, is an intermediate in the chain of enzyme reactions that produces energy in the form of adenosine triphosphate (ATP) from sugar metabolic products. A deficiency in this material may result in inadequate muscular function, particularly in heart muscle.

 Numerous trace minerals are important in proper enzyme functions in the digestive tract. Zinc, for example, has recently received widespread notice in the popular health food press. There are implications here for a segment of the baking industry. For example, unyeasted whole grain bread contains phytate, a component found in bran. Phytic acid can form a complex with zinc, rendering it unavailable to the body. In the 1950s, studies on populations in the Middle East, where unyeasted whole grain flat bread was a major component of the diet, revealed health problems traceable to this reaction. Yeast contains an enzyme, phytase, which hydrolyzes the phosphate ester linkages, rendering phytate innocuous. When these Middle East populations began consuming yeast-leavened bread, the problem disappeared. In the U.S. consumption of raw wheat bran is generally so small that this presents no problems. Another essential trace mineral is selenium. It is a component of an antioxidant enzyme, glutathione peroxidase. Selenium is thought to interact with vitamin E to maintain the required level of coenzyme Q. As with other essential trace minerals such as copper, cobalt, molybdenum and iodine, too much can be just as harmful as too little. FDA has established Reference Daily Intake (RDI) values for these minerals (except for selenium), and any fortification program including these minerals should be undertaken with some caution.

 Nutraceuticals certainly have a place in the total food supply picture. Particular segments of the population may need enrichment or fortification of certain nutrients, delivered in a palatable form. The challenge to bakers is to identify these segments and develop products that are appealing in taste and texture, and that will actually deliver the claimed health benefits.